Freyr Connect by Srinivas

Whatâ&#x20AC;&#x2122;s Inside

P.6 Article

Good Laboratory Practices - P. Murali Krishna

P.17 Travel

Visit to Horsley Hills - Soumma Chandra

P.23 Employee of the month

Interview with Azam Baig

Cover story

Employee Productivity - Nilofar Nigar

Supplement Inside

Printable Productivity Tools

CONNECT Vol. 1 Issue 3

From the

Editorâ&#x20AC;&#x2122;s Desk Dear Freyrians, This issue we bring to you a beautiful blend of professional and casual elements. Freyr Connect is focused on both aspects of employee workplace and seasonal elements like winter food and weekend getaways for this season.

In the following pages, we invite you to read through all the events that took place in the months of August, September and October and the events which are lined up for November and December. I would like to thank the contributors who have put in their efforts in coming up with some of the fantastic articles and making Freyr Connect more informative and interesting. We would love to hear from you and take your suggestions to make Connect the way you want it to be. Please write to nilofar.nigar@freyrsolutions.com for any ideas, thoughts, suggestions and any articles that you may want to get published in Vol 2. Issue 1. - Nilofar Nigar

People behind

Freyr

Contributors

Connect

Mahalaxmi Bedi

Soumma

Srinivas

Asst. Editor

Creative Head

Yasser Mohammad

P. Murali Krishna 1

What’s Inside

1 Note from the editor 3 Management Speaks 4 Positive Attitude: Article

HEALTH AND FITNESS

Food for Winter

Yasser Mohammad

Seasonal eating is a healthier lifestyle ! Although there are fewer foods that are in season in winter than in summer, winter for sure packs a punch in bringing some healthy and nutritious food around. Maintaining fitness is another thing that should be focused on during winter because our body’s chemical switch has flipped to storing more fat.

According to researchers ‘serotonin’ a mood-lifting chemical is produced in less amounts due to diminished sunlight and makes you feel weary, comfy, tired and hungry. Now this feeling makes us to consume more carbs that leads to more fat production.

Carrot - Full of carotene and vitamins. Lowers cholesterol and has anti-aging properties.

Turnip - Contains insoluble fibre, folates, vitamins and minerals.

Try having vegetables and fruits for breakfast & lunch and supplement little protein to your diet because it fills your appetite. Encourage yourself to have low-fat healthy carb foods and also don’t be too comfy on the couch to break a sweat. Here are some foods that bring essential and vital nutrients you need to have during the winter.

Mahalaxmi Bedi

6 Good Laboratory Practices: Article

Potatoes - A source of vitamins, potassium, protein, carbohydrates, calcium and fat.

Beet - Lowers cholesterol, blood pressure, depression and risk of liver/gall bladder conditions. Garlic - Stimulates production of white blood cells that fight infections. Spinach - Nutrient rich and a host of carotenoids and flavonoids. Prevents cardiac conditions.

Broccoli - Detoxifies and relieves from asthmatic symptoms. Apples - Cleans and detoxifies, helps to control insulin levels and lowers cholesterol levels. Oranges - Fights against infection and boosts heart health.

P. Muralikrishna

Guava - Has anti-oxidants and fights cardiac conditions.

8 Employee at Workplace:

Pomegranate - High in polyphenols that fight inflammation. Oats - Low-calorie food and stops cravings.

5. What are the ingredients of your success?

Interview with

My dedication to my work, my urge to deliver quality product on time and my constant drive to take Freyr to new heights – are the drivers of my success.

Azam Baig

6. Some suggestions for your subordinates would be?

Technical Lead

I started with the zeal of learning stuff and at the same time excelling myself with every project.

Employee of the Month

I worked hard and never bothered about the outcome. I would advise everybody to do the same because hard work always pays off in the long run.

‘‘

7. What is the most cherished relationship that you have in this company? I value the relationship that I have built with my managers. They have shown so much faith in me. We have a wonderful leadership team, who are ready to go to any length to make us feel comfortable.

My dedication to my work, my urge to deliver quality product on time and my constant drive to take Freyr to new heights – are the drivers of my success.

1. How has been the journey so far at Freyr? It has been an awesome journey full of hard work, fun and frolic. As much as there is learning at Freyr, so is the environment which promotes the same.

2. What was your learning curve? I joined Freyr as a Programmer Analyst. It took some effort and persistence on my part but I became a senior analyst in no time. Now I am the technical lead of a wonderful and hardworking team. At Freyr, opportunities to learn come at every step. Every day is a new challenge for us. It is how we take up these challenges is what matters in the end.

8. Any other interesting incident or moments that you have working with this company that you would like to share? For a certain project we had been given very stiff deadlines. We did not have any resource so despite being under the weather I came to office and finished the project on time. My manager was very pleased and not only did he send an appreciation mail, I was given a gift as a token of appreciation.

3. What do u think has been your major accomplishment? The DMS project has added a feather to my cap. I had the pleasure of working with the onsite team. We worked hard and delivered on time for which we were duly appreciated. These are small things, but at the end of the day add up to a lot of motivation which helps us to better ourselves with each project.

The friendly and cooperative atmosphere on the floor is something which we Freyrians are proud of. The management is easily approachable and open to discussion at any point of time – be it personal or professional, we get quick resolutions. We are well taken care of and we make sure that we give back our best.

TRAVEL

Weekend Getaways Let’s take a break!

Horsley Hills The Regulatory Affairs Professionals Society or the RAPS hosts The Regulatory Convergence every year, where the common denominator is an ambition to find out more and push things further. This is open to specialists and CEOs, directors and statisticians, consultants and recruiters.

‘‘

Professionals in research, clinical, pharma, medical devices, biologics, compliance, and at all different stages of the regulatory spectrum and product lifecycle attend this conference every year. And The Regulatory Convergence is where you come to figure out how to turn drive into action. Rajiv Rangan, CEO, Freyr Inc. attended the RAPS conference this year at boston on 28th September- 2nd October.

About RAPS The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.

Employee

Nilofar Nigar

17 Travel: Weekend Getaways

Soumma Chandra

20 Appreciation

Azam Baig

25 Life at Freyr - A Fresher’s Perspective Freyr Inc. sponsored the 5K Run at RAPS. The delegates appreciated the service offerings that Freyr as a company has in the regulatory space.

Visit to

Yes! You read that right. Enough of team meetings, metrics, submissions, projects, deliverables, trainings, oh my God… the list goes on and on. This makes us think that we deserve a break, don’t we?

The Regulatory Convergence 2013

Tools for Employee Productivity

21 New Employees 23 Interview: Employee of the Month

4. What is the best thing about this company?

RAPS Conference

Productivity

Rajiv Rangan

26 GPW Committee Launch

Nilofar Nigar

27 Fun at Freyr 29 Birthday Celebrations 30 RAPS Conference

Rajiv Rangan

31 Health and Fitness: Food for Winter Nilofar Nigar

“At the outset, workplace productivity seems to be an issue which can be easily identified, measured and monitored. However, veteran business leaders have acknowledged that it is one of the most complex, multifaceted areas that need immense attention. And in an ever-growing competitive global market, effective workplace productivity is extremely critical.”

Yasser Mohammad

32 Technology: Techbuzz for Professionals

Yasser Mohammad

34 Upcoming Events Employee Productivity & Cover Picture Courtesy: Victor 1558 @ flickr.com

Management

Speaks Srini Sadhu

Suren D

Sunitha A

Vasu R

Rajiv Rangan

Sudheer G

We are excited to announce this issue which encapsulates the recent happenings in the company. The various activities which have taken place during the past couple of months have strengthened the company and have led to a surge of positivity amongst all of us. We are proud that not only are we increasing in numbers and expanding our global footprint rapidly, but we are also strengthening our base. We have laid extreme importance to the growth of the company in terms of launching new initiatives, expanding the services that we offer as well as nurturing the skills of our employees who we believe to be one of our greatest assets. We hope this issue suffices the purpose of strengthening the bond of Freyr as a family and in providing the relevant information of the happenings across the organization along with a taste of fun.

POSITIVE

ATTITUDE

‘‘ Mahalaxmi Bedi

Ever since I started imparting training on soft skills and personality traits, I have been focusing in imparting training to the employees. However things have changed in the current era and with the emerging trends like organizational change, companies are either “downsizing,” “rightsizing,” “merging” or “being acquired.” Thousands of people who used to think that their lives were secure are now suddenly vulnerable. Some will become unemployed, and those who remain will wonder when their turns will come. At times we are defeated by circumstances if we allow circumstance to decide the path our life has to take. I know a number of people who are facing this issue. Some people are clever enough to get the better of the circumstance; they wean away the opportunity from that circumstance and use it as a stepping stone to achieve their target. People who have a predominantly negative attitude are a challenge to deal with. These are the kinds of people who have the power to influence others as much as somebody with a positive attitude. The difference lies in the results.

I believe that imbibing positive attitudes in the employees is a organization wide concern and has to be embedded in the organizational culture and reflected across all levels.

Positive attitude in the workplace has many benefits, including:

Improved Communication Better Teamwork Increased Morale Higher Productivity

The opposite is true for negative attitudes. Teamwork goes for a toss, stress increases and productivity reaches an all time low. Winners are distinctly different from the losers by the kind of attitude they put up at the workplace. The salesperson who sells more, the manager who inspires his people, the manufacturing supervisor who sets the tone for everybody around them, are all good examples of what attitude does for you and everybody around you. My former colleague (let’s call her “Priya”) had the habit of instilling negativity (if i may say so). When an idea was presented, she was the first one to say, “That won’t work.” Fair enough. But she never offered alternatives. She never looked for solutions. She never, ever gave anything or anyone the benefit of doubt. Priya was an absolute nightmare to work with. 4

I understand that some people are just naturally more positive than others. And I truly believe that every operation works best when there are a wide variety of personalities in the mix. But negativity for its own sake rarely serves a purpose. And people who can’t demonstrate a positive “can do” attitude in the workplace are truly damaging their career as well as spreading negativity in their circle of influence.

Now, let me also be clear: Voicing a dissenting opinion, speaking assertively and saying “no” are not inherently negative. You can and should embrace your individuality and your professional power. But your delivery has a huge impact. Done in the wrong way, these things can certainly appear disturbing.

Why Attitude Matters: You may be thinking, “What’s the big deal? I’m just being honest. I have to voice my opinions and be myself. I don’t do the fake stuff.” That’s fine. No one’s asking you to fake it…much.

‘‘

The workplace is a living, breathing organism and everyone impacts it. Your negative attitude can bring down the entire structure. It is as contagious as an airbourne virus.

Strategies for

Demonstrating Positive Attitude Smile

It’s amazing how powerful a smile can be which I love the most. A smile can change your mood considerably. Even if it is one of those sad days, try and put on a smiling face and you will subsequently see the difference in the attitude of the people you deal with. It may sound cliche, but as they say: ‘Smile is only a curve that puts everything straight in life’.

Seek Solutions

When going gets tough, tough gets going. If you are stuck at some point, put on your thinking caps and start looking for a solution. Instead of washing your hands off and quitting, approach it like a puzzle. Some questions like these really help: How can we turn the situation around? How can we fix the problem? How can we make this work? It is fine to be skeptical, but bring your own ideas to the table as well.

Remain Professional

Frustration, anger, disappointment, etc. bring no benefit. Do your best to set these feelings aside. The workplace is a professional environment— and it is your responsibility to act professionally. That means using tact and diplomacy, stating facts before feelings, and finding ways to get the job done— even when it is uncomfortable.

Respect the Team

Positivity brings a feel good factor in those around you. Give your team members the respect that they rightly deserve. Even if you are not feeling too great, focus on the bigger picture. You are a part of the team and your attitude matters. A little effort goes a long way. Positive attitude is like a boomerang: It always comes back to you. The more you project a positive attitude, the more positivity will come your way. You do not have to pretend to be someone else. Just recognize the powerful force that is within you, your attitude would reflect the same, and finally you can use it to your advantage.

GOOD LABORATORY PRAC TICES

â&#x20AC;&#x153;

Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance. This assures the regulatory authorities that the submitted data is in accordance with the results and reliable while making decisions regarding safety assessments.

About the author:

P. Murali Krishna works as Regulatory Affairs Manager

â&#x20AC;&#x153;

at Freyr Inc. He has extensive experience in GLP, cGMP and Regulatory Audits. Murali has worked with big pharma MNCs like Ranbaxy, Johnson & Johnson and Novartis for more than 10 years. He has earned his Masters in Industrial Chemistry.

Operational process for analytical laboratories is greatly influenced by the GLP regulations and guidelines. GLP functions as a regulation which deals with the specific organizational structure and documents related to laboratory work in order to maintain integrity and confidentiality of the data. The entire cost of GLP based work is about 30 percent compared to non-GLP operations.

Standard Operating Procedures must be

followed.

Calibration and maintenance of instruments.

Right construction of laboratories to maintain

integrity of the study.

Raw data should be processed and achieved.

Requirements for GLP based operations-

Employees should be well qualified and trained as per the job assigned.

To assign responsibility for sponsor management, study management and quality assurance. 6

MANAGEMENT PROCESS OF GLP 1. Personnel: Sufficient number of qualified employees must be a part of this (Qualification can be relevant educational background, experience or training). Apart from this, job profiles, tasks and responsibilities must also be documented. 2. Facilities: The three main requirements for facilities include limited access to the building rooms, adequate size and construction. This includes a number of responsibilities listed below o Monitoring the entire study process. If there happens to be any discrepancy in the process, then the study director is replaced.

o Ensuring that quality assurance unit is available to handle tests and control articles.

o Availability of sufficient qualified personnel for study. o Animal care facility requirements.

3. Study Director: The study director is responsible for technically conducting safety studies, analysis of the results and interpretation, documentation and reporting of the results. 4. Quality Assurance Unit (QAU): It serves to control internal functions. To ensure that facilities, devices, personnel, practice, protocol, records, SOPs, reports and archives are in accordance with the GLP regulations.

6. SOPs: Standard Operating Procedures (SOPs) specify the manner in which protocol specific activities are carried out. SOPs are preferably written and reviewed by instrument operators. The working of SOPs ensure that information is accurate and document is liable for routine use. 7. Reagents: The quality, purchasing and testing of reagents and solutions used for GLP studies shall be handled by QAU. 8. Control Articles: Control articles are also referred to as reference substances by OECD. They are commonly used to calibrate the instruments. 9. Retention and Retrieval of Records: GLP regulation specifies how records are stored and retrieved. 10. Inspection: FDA is responsible for inspection of GLP studies before a drug or device or any other product is marketed in US. There are 2 types of inspection programs. o Routine Inspection o For-cause Inspection 11. Enforcement: Any deviations discovered by the inspection team are documented and discussed at the exit meeting. The lead inspector prepares an establishment inspection report based on the findings discussed during the meeting. A warning letter is issued to the companyâ&#x20AC;&#x2122;s management following which corrective action plans are implemented by the company within 14 days.

5. Equipment - GLP regulations also specify requirements for equipment - Design, Maintenance, Records and other documents.

GLP is needed to regulate all non-clinical safety studies. GLP can be applied to short term as well as long term studies. This regulation is a must for non-clinical safety studies of drug development process, food control products and development of agricultural pesticide and toxic chemicals.

In a nutshell Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment.

GLP is also required for registration and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products for all regulatory authorities.

Employee

Productivity

Nilofar Nigar

â&#x20AC;&#x153;At the outset, workplace productivity seems to be an issue which can be easily identified, measured and monitored. However, veteran business leaders have acknowledged that it is one of the most complex, multifaceted areas that need immense attention. And in an evergrowing competitive global market, effective workplace productivity is extremely critical.â&#x20AC;?

In the most basic form productivity implies the output in a specific period of time or in the economic sense it is measured in terms of ratio of output to input. Retaining employees and keeping them productive at work is indeed one of the major challenges in any organization. However keeping the employees productive at workplace requires a lot of effort and involves subsequent trainings to be given at each level at the organizational hierarchy.

Higher productivity also resonates with having adequate time for the employees to be more creative so that they can find time for innovation and can make strategies for their work unit. This time can be utilized effectively into thinking how to apply best practices into the work and to plan for something new like new products and/or services or effectively managing the existing ones along with making the existing workflows better and more effective.

AMBITIOUS

AUTONOMOUS

RELIABLE

Traits

IDEAL

EMPLOYEE

of an

DETAIL ORIENTED

CHARACTER DRIVEN

CONFIDENT DILIGENT ACTION ORIENTED

Multi-Skilled

HONEST POSITIVE

LEADER RESPONSIBLE

CULTURALLY FIT DEPENDABLE

PROACTIVE SELF-DISCIPLINED

DEDICATED 9

Tips for

being ive t c u d o pr

vice:

** Seek Ad

try you should , rk o w t a k ding the u get stuc ste time fin a w henever yo t W o n o d yourself: some form of exercise, to seek advice so that wyohuen you do not have one. n o s u c o F ** ation or ws and olutions with medit ding the morning ne propriate s p y a a d e: r u . o y rs a ou Start Delete-Fil log your inbox to e food, and re pdates at the early h t t a h g g ri e le e th eating levant u ils that c ** Do-D always rtant and re ber of ema o p m u im n r to, there is e e r rg th te la o a c e u th o h y t do the Wit rst: fi most s rojects tha u need to p k e o y s th le if a h t , ip it lt r le u lt w ru ** Difficu er to start your work dayte those, you are the med to follow this simple r delete it if it does not cactetly a ne bett t dire mple me, o but are no It is always gate the sa nce you co s. Also, starting this â&#x20AC;&#x2122;d le O c . e c d d n r re a o a h , k t u s me), or ta yo ks a task eed your ti ny emails n a c at the difficult tas s on other t ti u m e o c n n rg fo (i e y n a n u a e o c to y you t email m re more at ease and d as you a ed and tha on it later. e n d o n ti e n e m m m o r working way is rec work. stly file it fo f la o rs u o h etings: e m early t h ig r nd, keep se the ils: o a o l media ant to atte nd do m ia h w E c C o l u s a * o r y * n u s o o y g meetin hecking the day a ** Pers osy in the time for c riorities for o p h te c t ra h e a g B p ri e e s th nding it. Take out ake of atte al emails. focused on s n lf e o e rs th rs e r u p o fo y d s n meeting accounts a just attend t o n s k a re edia b clean: lean ** Breaks: reaks form work. Sociatil mme breaks that ** Keep your desk your desk c e p e e k to b f y ent ee utes a da nding th nt forms o Take frequ quick coff ues while fi ote five min s ost prevale v m is e o m y d fr n e s a y rt th a m a f t p o s more lw u r a A are one you to focu d. It sorts o r compute ays prefer s u re o e -d lp y e tt -a h lu w m o c o o n ls n fr a u and re away office desk and employees point to sta ick walk around your ing at your a ly s e g k a in . M th y a s. u break ke a q out the d time and ta sh through e at work. fr u o y from time to p kee to s lp e h . ork. ology: n h 0 rule c /2 e 0 t block. This 8 e e oing your w g s th d t U in e * u rg * o fo y t t o comin ls to assis Lastly, do n grouping in store t set of too s h a g ri : le e â&#x20AC;? p d o th n im a e s N s h U say â&#x20AC;&#x153; are as ystem to work in ** Learn to r to be organized and takeeverything and Some of the toctroolsnic data managemenutlisng program for d ing ele bette rsonal sche ry of contacts. e er than tak jects which you messages, p It is always th d ra n a e s, m ti e file have the pro t, & directo a and find th when you to deliver ling plays work layou u r, le d a b e d a h n c g le s a in e c e v -do list, rtant then not b ommitted to. Effecti ork is impo le to w c h y ic d h a w e lr have a schedu uld know re. You sho ention, which ones to e h le ro y e ed your k mediate att hich one does not ne im s d e e n w and y and rt of the da for later pa time.

What Can Management do to Improve Employee Productivity? FRRITTS Model, as we call it now is essentially some of the recommended things that the management of any organization should do in order to ensure that their employees stay motivated and productive at the workplace. However, instilling organizational values in the employees and making a culture which promotes innovation and productivity, is highly critical to any organization. The below diagram depicts that each of the elements is extremely vital.

PRODUCTIVITY Creation:

TOOLS

The management must give appropriate feedback to the employees from time to time. However it is necessary that the tone should be kept positive. Each employee should pay respect to every other at the organization irrespective of the level and the nature of the work they do. Monetary appreciation also motivates the employee and makes them perform better at work but verbal appreciation and other forms of recognition is also mandatory. Training should be conducted at regular intervals in order to develop the employees so that they feel more confident at the work place. And last but not the least the management must provide the right set of tools and be supportive to its most important asset, â&#x20AC;&#x2DC;Employeesâ&#x20AC;&#x2122;.

Finding Facts:

Quip, Evernote, Paper, Haiku Deck, Lucidchart, Prezi, Visual.ly, WriteMonkey

Fact Browser (http://www.factbrowser.com/)

Storage and Sharing: Box, Dropbox, Hightail

Creative Commons (http://search.creativecommons. org/) and Stock Photos from Hubspot

Reporting:

Content Declutters:

Mixpanel, Quantifind

Adblock google chrome extension

Finding Files:

Website Blockers:

Alfred for Mac, Everything for Windows

StayFocusd for Chrome, WasteNoTime for Safari, and LeechBlock for Firefox.

Tracking:

Finding Images:

Yast, Bitrix24, Asana, Todoist, Chrometa, Desktime, Toggl, Trello

Blocking Distractions:

Training:

Email and Social:

Udacity, Thinkful, Codeacademy

Hootsuite, Sanebox, Lastpass password manager

Cold Turkey

Supplement: Printable

Productivity Tools

This supplement focuses on some of the basic printable and downloadable tools from David Sleah.

TRAVEL

Weekend Getaways Let’s take a break! Yes! You read that right. Enough of team meetings, metrics, submissions, projects, deliverables, trainings, oh my God… the list goes on and on. This makes us think that we deserve a break, don’t we?

Visit to

Horsley Hills Soumma

Things to do/must see while youâ&#x20AC;&#x2122;re there

Koundinya Wildlife Sanctuary

Gaalibanda

Highview Seeing Place

Horsley Hills Museum

Adventure Sports: Trekking around the hills

Lake Gangotri 18

Preparation for the trip to Horsley Hills: Plan at least a week ahead. You would need to reserve accommodation in advance as there are not many options to choose from. Also, make sure that you have your pair of trekking boots, those simple and hassle free pair of cargos and some useful medicines (not to mention some mosquito repellants). You have to stock up with hard cash as ATMs are very few and far in between. Also, the local shops do not accept cards. Make reservations for the bus or train. So what are you waiting for? Pack your bags and get set to go. Have fun, come back refreshed and gear up for another week at work. And we will be back with another nice place to visit, the next time you need a break.

But alas, no leaves, no festivalsâ&#x20AC;Ś. Oh!! Wait! What about weekends? We surely can give up grocery shopping and washing clothes for a short and refreshing trip up into the hills. Just about 500 kilometers away from Hyderabad, there is a quaint little hill station called Horsley Hills. It is just a 7 hour drive from the city. It is a must go for people who want to rough it out. Full of adventures and trekking, Horsley Hills is the perfect getaway from the bustle and din of the city. It is a heaven for bird watchers also.

How to get there? Travelling by bus is the best option as seats are available easily and the journey is quite short. Also the scenic view of the road earns an extra point over the train. Another disadvantage with the train is that it is bi-weekly and it goes up to Tirupati, which means you have to get down and drive back.

Appreciation

Deepika M. She completed multiple submissions on time without any quality issues. The efforts she put in the past couple of months helped the team considerably in accomplishing the key goals.

- Mallikaarjunan R, Regulatory Operations Senior Manager

Parimal Limburkar We had promised to provide the gap analysis of a particular drug to the client. This was re-assigned to Parimal under an extremely short notice. He worked on the weekend to complete this task and finally we were able to deliver the gap analysis well within the agreed time.

- Vikas Bharadwaj,

CMC Regulatory Affairs (EMEA)

Yasser Mohammad He is a dedicated and hard working resource. He has grown phenomenally in terms of widening his expertise and his contribution towards new closures is highly appreciated. Yasser has been extremely proactive in developing some fantastic prezi presentations and writing blog articles to move up the thought leadership position of Freyr Inc. - Kalyan Reddy,

Yasmin Mohammad She has done an immense job in closing more than 6 requisitions within a span of two months. The turn-around time is highly commendable.

- Sunitha A.,

Managing Director

Manager Business Alliances

New

Employees in Freyr Family Lakshmi Reddy (General Manager Regulatory Affairs) has over 9.3 years

of experience in Regulatory Affairs and 1.8 years in International Drug Regulatory Affairs. Previously, he worked as Sr. Manager in International Drug Regulatory Affairs with Famy Care Ltd. (For Mylan Laboratories Ltd.), Navi Mumbai. He has experience in handling solid oral dossier filings (Oral contraceptive Products) for US/EU/NZ in eCTD format and in handling solid oral dossier filings for Brazil. Lakshmi’s expertise also lies in advising and guiding plant, and research and development on regulatory requirements for new product development and project registration details.

Gautam Kalagara (Program Manager) has over 4.5 years of IT experience

including 2.5 years of SDLC/Regulatory experience in life sciences Industry, as an implementation engineer/ publisher in a software operation team, which provides effective technical solutions to various pharmaceutical companies that are associated with electronic submissions of New Drug Applications (NDA) to the regulatory agencies in countries across the globe. He has worked for Yashoda Hospitals, Hyderabad as Manager- Quality Assurance and Certification.

Parimal Limburkar

(Manager-Regulatory Affairs) has more than 5.4 years’ of Experience in Drug Regulatory Affairs (Operations). Earlier he has worked as Assistant Manager with Mylan Laboratories Ltd., Hyderabad. He has compiled data and documents into ICH or respective EU/APAC/SOUTH AFRICA Health Authority- acceptable format (CTD/NeeS/eCTD) for filing as an Abridged Marketing Authorization Application (AMAA), variation applications for assigned projects covering different dosage forms like solid orals, ophthalmic and injections.

Mahamud Ali Shaik

(QA Lead) has 9 years of IT Experience which includes software quality assurance and software manual testing. He has in-depth knowledge of CMMI Level III Process Implementation (Project Management, Process Management, Engineering, Support). Mahamud has extensive domain knowledge of ISO 9001: 2008 (Quality Management System) and is a Qualified Internal Auditor. He worked as a “Quality Analyst” for AMI Tech (India) Pvt Ltd.

Venu Gopal

(Process Operations) has around 7 years of Experience in Process Operations, Quality and People Management in the Artwork Pack Management Projects in Pharma and Consumer Industry. Previosly he worked for Tech Mahindra BSG (Formerly known as Mahindra Satyam) in Artwork and Labeling Process as Senior Team Lead.

Arey Srikanth (Facility Manager) has more than 7 years of comprehensive

experience in General Management, Facilities Management, Personnel Management, and Administration and implementing cost and time reduction measures. He worked at Business Communication Network Solutions (BCNS) as Assistant Manager – HR/Administration.

Shiva Prasad (Senior System Administrator) has six years of experience as System Administrator. He is extremely efficient in operating Windows and Linux servers environment and other system integration related components. Shiva has actively participated in the planning and implementation of system/server monitoring, maintenance and support of all application software and operating systems. Previously he worked as “Systems Administrator” for Netxcell, Hyderabad.

Abdul Razaq

(System Administrator) has 1.9 years of experience as System Administrator. Previously he worked with CAT Technologies as System Administrator and has excellent hands-on experience with LAN/WAN networks, RAID controller configurations and routing and switching protocols including TCP/IP and integrating IP networks.

Azharuddin Khaja (Talent Acquisition Specialist) has more than 3 years

of experience in Talent Acquisition. He worked as Senior Recruiter with Sameva Global, Hyderabad. His expertise lies in detail oriented sourcing and screening the candidates. He applies the best sourcing methodologies and goes beyond the traditional tools to search candidates from various other social media channels.

Interview with

Azam Baig Technical Lead

Employee of the Month

‘‘

My dedication to my work, my urge to deliver quality products on time and my constant drive to take Freyr to new heights – are the drivers of my success.

1. How has the journey been so far at Freyr? It has been an awesome journey full of hard work, fun and frolic. As much as there is learning at Freyr, so is the environment which promotes the same.

4. What is the best thing about this company? The friendly and cooperative atmosphere on the floor is something which we Freyrians are proud of. The management is easily approachable and open to discussion at any point of time – be it personal or professional, we get quick resolutions. We are well taken care of and we make sure that we give back our best. 23

5. What are the ingredients of your success? My dedication to my work, my urge to deliver quality products on time and my constant drive to take Freyr to new heights â&#x20AC;&#x201C; are the drivers of my success.

6. Some suggestions for your subordinates would be? I started with the zeal of learning stuff and at the same time excelling myself with every project. I worked hard and never bothered about the outcome. I would advise everybody to do the same because hard work always pays off in the long run.

Life at

Freyr Fresher’s Perspective

Let us share our cheerful experience at Freyr so far. For a fresher with a Pharmacy background, a job in Regulatory Affairs is a dream job, which in our case has come true after getting hired by Freyr. Not many companies offer freshers a chance to get involved in multiple projects within a considerable short span of time. But we are fortunate to be at Freyr, which believes in our potential and has given us an opportunity to learn and explore from various dimensions by being placed in multiple projects.

‘‘

The platform given to us has not only raised us to a great extent as professionals and domain experts but has also endowed us with extreme learning curve which is growing day by day.

to have friendly colleagues who always extend a helping hand whenever we need. Having lot of fun has been an essential element here and we heartily participate and enjoy the regular fun activities conducted by Great Place to Work Committee. Last but not the least, we would say that the journey so far has been beautiful and we are looking forward to many such memories while we continue to step up the professional ladder. Courtesy: Ch. Prashanth, M. Sunil Kumar, Krishna Kiran, K. Sandeep Reddy, T. Sandeep Rao, G. Rayappa Reddy, C. Sravan Kumar, P. Praneeth Kumar, K. Prateek

The best thing for a fresher at Freyr is the flexibility that it provides us. This flexibility is the open platform for us to learn and explore any domain without intervention. All the more the management has been extremely supportive in terms of providing us with varied training to groom ourselves as better professionals as well as great individuals. Working at Freyr feels like working at home with supportive administration and comfortable work environment. Freyr for a fresher is like a huge bowl of knowledge where one can improve in huge ways. We are glad to be part of the Freyr family and are blessed 25

GPW MEMBERS

GPW

Committee Launch Vikas Bhardwaj

Chandrakanth Pasham

Haribabu Thirumalasetty

Phanichand Mokkapati

Sovan Mahapatro

Shivaprasad Pandit

Srikanth Kuruva

M. Vishnuteja

The Great Place to Work or GPW Committee was launched in the month of September. This is a step towards making Freyr the most preferred employee brand in the industry that we operate in. The members of this committee are employees from various functional departments. The committee is responsible for conducting fun filled activities/sports/games at Freyr, Planning and implementing CSR activities, Supporting HR in University Relationship campaigns, Conducting quarterly/biannual award events, and Conducting any social events (Diwali/New Year etc.)/get together/health campaigns. The GPW members are a part of the most exciting committee of Freyr. During the past experiences it has been observed that employee/organizational benefit oriented committees like these, have served as an excellent platform to hone the leadership skills of the members, and they have grown as excellent leaders. Having said that, employees as well as the organizations had and still continue to benefit largely from this committee in making the employees more engaged into the organization and making the environment one of the best places to work. We look forward to seeing some excellent activities and initiatives from the GPW Committee. - By

Nilofar Nigar Srikanth Bingivar 26

Fun at Freyr:

Ethnic Wear & Dussera Celebrations

Fun at Freyr:

Diwali and Rangoli Celebrations

Birthday Celebrations

RAPS Conference The Regulatory Convergence 2013

â&#x20AC;&#x2DC;â&#x20AC;&#x2DC;

Freyr Inc. sponsored the 5K Run at RAPS. The delegates appreciated the service offerings that Freyr as a company has to offer in the regulatory space.

The Regulatory Affairs Professionals Society or the RAPS hosts The Regulatory Convergence every year, where the common denominator is an ambition to find out more and push things further. This is open to specialists and CEOs, directors and statisticians, consultants and recruiters.

About RAPS The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, nonlobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.

Rajiv Rangan CEO, Freyr Inc. 30

HEALTH AND FITNESS

Food for Winter Seasonal eating is a healthier lifestyle! Although there are fewer foods that are in season in winter than in summer, winter for sure packs a punch in bringing some healthy and nutritious food around. Maintaining fitness is another thing that should be focused on during winter because our body’s chemical switch has flipped to storing more fat. According to researchers ‘serotonin’ a moodlifting chemical is produced in less amounts due to diminished sunlight and makes you feel weary, comfy, tired and hungry. Now this feeling makes us to consume more carbs that leads to more fat production. Try having vegetables and fruits for breakfast & lunch and supplement little protein to your diet because it fills your appetite. Encourage yourself to have low-fat healthy carb foods and also don’t be too comfy on the couch to break a sweat. Here are some foods that bring essential and vital nutrients you need to have during the winter.

Yasser Mohammad

Carrot - Full of carotene and vitamins. Lowers cholesterol and has anti-aging properties.

Potatoes - A source of vitamins, potassium, protein, carbohydrates, calcium and fat.

Turnip - Contains insoluble fibre, folates, vitamins and minerals.

Beet - Lowers cholesterol, blood pressure, depression and risk of liver/gall bladder conditions.

Garlic - Stimulates production of white blood cells that fight infections.

Spinach - Nutrient rich and a host of carotenoids and flavonoids. Prevents cardiac conditions.

Broccoli - Detoxifies and relieves from asthmatic symptoms.

Apples - Cleans and detoxifies, helps to control insulin levels and lowers cholesterol levels.

Oranges - Fights against infection and boosts heart health.

Guava - Has anti-oxidants and fights cardiac conditions.

Pomegranate - High in polyphenols that fight inflammation.

Oats - Low-calorie food and stops cravings.

TECHBUZZ for

Professionals

Yasser Mohammad

Did anyone else have the same question “How can I make Work made enjoyable is more productive and acts as a my work enjoyable” ? Let’s see. self-booster. Below are some personal recommended upgrades, a whole brand new range of exciting and Typically most people working in an office tend to fun gadgets that will add some color to your daily work spend their lives in a pretty dull work area with the same station and office. people every day working well over 40 hours a week. To make matters worse most offices are uninteresting, monotonous, unoriginal and lack liveliness…but there is something that we all can do about it.

Pico Projector Pico projector is the boss when you need to show a presentation or a video from your phone to a larger audience. Compatible with almost all the operating systems, all it requires is a phone to plug in. Cool gadget for presentations, handy, audio jack for speaker, also connects laptops, netbooks and game consoles. With a price tag of $150 its a great buy.

Myo Does anyone remember the movie Minority Report, where Tom Cruise has this interactive and cool screen on the glass where he controls without touching. Well, geeks looking for something more than Pico Projector, Myo serves the purpose. It is my personal favorite usable for business and fun purposes. Myo - made by Thalmic Labs, is a wearable gesture control arm band. Still not available in the market until 2014, Myo tracks the electrical impulses in your muscles and allows certain gestures to execute actions - e.g. a simple wave of your hand can lower volume on your laptop, rewind, forward, pause, stop the videos or presentations. Watch the video at www.getmyo.com. 32

DocuSign Need a signature on a contract document and you have no time left ? With DocuSign you can sign your official documents and agreements electronically on your phones and tablets. For less than $ 15 per month you have access to a platform that is legal, secure and online. Trusted by 48 million users worldwide, it is a time saver.

XDModo Solar Charger Best buy for Eco-friendly species. Sleek model covered with solar cells on one side, sticks to the window, USB port, comes in black, green and silver.

Penultimate Penultimate developed by Evernote itself is a wonderful application that provides a writing and drawing interface making the experience of writing in ink better. You can choose your choice of sketch and color, and share it with everyone. On top of all that, it gets synced and saved in your Evernote account.

Upcoming November

Events 4

Clinical Cosmetic Safety Assessment

by Tushar

for Regulatory Affairs

Types of Regulatory Submissions in Europe

15 16 by Vikas

for Regulatory Affairs

Freyr 18 Sports Week 17 19 20 21 28 29 Fundamentals of eCTD Submissions by Malli

for Regulatory Affairs

Life Cycle of Drug Approval by Gautam

for Regulatory Affairs

Environmental Issues by Prateek

by Nareen

for All Employees

for Software Dev Team

HTML 5

December

5 6 12 13 18 19

Medical Writing

Body Language

by Soumma for All Employees

Team Building

by Soumma

for All Employees

Annual Event

by Sunil

Quiz

for Regulatory Affairs

eCTD Structure

HTML 5

by Gautam

by Nareen

for Regulatory Affairs for Software Dev Team

European Procedures by Lakshmi Reddy

for Regulatory Affairs

Stress Management

27 by Shubhi

for All Employees

Freyr

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• 21 CFR Compliant Submission Preparation • SFDA, FDA, EU - Regional Submissions • eValidator feature for Submissions • NeeS Preparation

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Global Regulatory Responsibility Services Regulatory Business Consulting Services

Regulatory Strategy

Regulatory Centralization

Product & Market Strategy

Global Regulatory Process Standardization

1 Health Authority Directives & Mandates EVMPD/ IDMP Compliance (EU directive) PSMF ( EU Directive) Cosmetic Safety Assessment (EU directive) Metal residue specification Limits ( EU directive) Shelf Life Data ( FDA Directive)

Regulatory Business Consulting Services

Regulatory Strategy

Health Authority Comprehensive Regulatory Directives and Solutions Mandates

5 Regulatory Information Management

Regulatory Data Management (Freyr PRM) Products, Market Registrations, Commitments Tracking, Market Application Lifecycle Management, PSMF metrics Regulatory Document Management (Freyr DMS) SMPC, Labeling Documents, Submission Documents, Company Core Data Sheet Management, Product Dossiers, Market Registrations/Licenses, Trial Master Files, Legal and Audit Compliance Documents Regulatory Submissions Management (Freyr SUBMIT) Market Authorizations, Application Life Cycle submissions, Safety Variations, CMC variations, PSURs, EVMPD

Regulatory Affairs

Regulatory Information Management

Regulatory Affairs

4 Regulatory Operations

Dossier Preparation CTD Modules CMC and Change Control Labeling Clinical Safety and Toxicology Assessment Clinical Study Reports Cosmetic Safety Assessment

Regulatory Operations Submission Management (Electronic, Paper, eCTD, NeeS) Artwork Management PSMF Compliance Management Raw Material Management