DORUKSISTEM PRESENTATION 2019

‘The heart of TURKREACH KKDIK’

‘Your ‘when Partner in Turkey’ Quality is your Priority’

www.doruksistem.com.tr

Doruksistem Engineering, Technology, Consultancy and Chemical Management Systems Inc. Co. DORUKSISTEM Engineering Technology and Consultancy Co Inc. was established in 2005 to guide and lead to the chemical industry, industrial chemicals cosmetics manufacturers – pesticide/agrochemicals/biocidal products registrants, grower/commodity groups, trade associations exporters, importers and chemical process industry to compliance with Turkish, EU and global regulations and in dealing with issues that affect their ability to do business effectively.

DORUKSISTEM consultants have been involved in the preparation of vulnerability analyses, including the evaluation of regulatory, quality control, and business systems, and the development of standard operating procedures, global regulatory models, and compliance manuals and programmers. With a strong presence in Turkey, DORUKSISTEM has provided cost-effective regulatory support and testing services to many valued companies while doing businesses in both the EU and Turkey.

DORUKSISTEM is the most experienced leader consultant company in Turkey and your partner on the way of TURKREACH (KKDIK).

Our Expertise Our regulatory expertise includes regulatory consultants and scientists who have extensive experience dealing with Turkey, EU, and global issues and regulations.

We assist chemical manufacturers, cosmetics manufacturers, pesticide registrants, grower/commodity groups, and trade associations in dealing with issues that affect their ability to do business effectively.

Our regulatory consultants and scientists provide strategic advice concerning regulatory compliance.

«Big Picture»

Doruk Sistem’s consultants work with clients to consider the “Big Picture” by assessing and integrating the regulatory, technical, strategic, and business aspects of each issue on local and global levels.

Using this integrated approach, our consultants advise clients on issues such as product registration, due diligence, registrability assessments, product development, product stewardship strategies, experimental use permits, and reduced risk submissions.

Doruk Sistem consultants have been involved in the preparation of vulnerability analyses, including the evaluation of regulatory, quality control, and safety systems, and the development of standard operating procedures, global regulatory models, and compliance manuals and programs.

OUR CAPABILITIES •

•

•

•

Doruk Sistem’s Center for Chemical Regulation and Industrial Safety specializes in timely, high-quality, creative, and practical solutions to problems that affect our clients' ability to conduct business local and globally.

Our experienced staff includes both technical and regulatory consultants who are experienced in dealing with with pesticide and non-pesticide products, including conventional chemicals, biochemicals, agrichemicals, microbials, antimicrobials, consumer products, and products of biotechnology.

We draw upon expertise in a variety of backgrounds, including epidemiology, biostatistics, toxicology, ecotoxicology, environmental sciences, and risk modeling, to best meet our clients’ needs.

Our international team and partners of regulatory and scientific experts offers additional support for agrichemicals and biocides regulated under Turkey, EU and US directives. Whatever your needs, Doruk Sistem can augment your regulatory team and provide flexible, strategic consulting.

Our History 2005 - DORUKSISTEM founded in Istanbul, Turkey.

2006 - DORUKSISTEM launched leading edge solutions for authoring and managing production quality and R&D management systems for the chemical process industry.

2007 - DORUKSISTEM completed more than 50 TSE/TSEK certification for the Turkish chemical industry.

2008 - MSDSMARKET is established and published on www. msdsarket.com.tr 2010 - DORUKSISTEM Head Office opened. More than 4,500 CICL (Chemical Inventory Control Legislation) notifications completed for several global companies.

2011 - DORUKSISTEM awarded ISO 9001 by Bureau Veritas.

2012 - Process safety department established.

2013 - Process safety business started.

2014 - More than 35,000 SDSs completed according to Turkish SDS legislation (DSD/DPD/CLP) in total.

2015 - DORUKSISTEM R&D Technology branch opened at Tubitak Research Complex in free zone Martek Kocaeli Area.

2016 - DORUKSISTEM approved as an associated member of ORO, the Only Representatives Organisation 2017– DORUKSISTEM moved all facilities to TUBITAK MAM Marmara Technology Free Zone Area as an approved R&D company.

2018 – MoEU appointed DORUKSISTEM as Approved Chemical Assessment Specialist Training Company, DORUKSISTEM started to process KKDIK pre-Registrations (pre-SIEF & C&L Registrations) for International and local companies.

OUR SERVICES «Chemical Management Systems»

    

Monitoring & Following Documentation and Licensing Notification and Registration Consulting and Advisory Compilation

Monitoring Local and International regulatory changes Turkish Chemical Control and related Regulations, Export and Import testing and analysis, procedures follow-ups, Turkish Standards Institution’s Certifications, etc. TURKISH Chemical Control Regulations Compliance Services TURKREACH KKDIK, TR-CLP SEA, TR-SDS GBF, SEVESO, ATEX, IPPC, etc. regulations compliance Product Safety Compliance Biocidal Products, Plant Production Products, Veterinary Products, Cleaning Chemicals etc., Regulations and import permissions & licensing services Following up of the industrial legislations and import documentation and certification etc. Following up & warning services on the industrial legislations, General consultancy on Turkish and International chemical regulations Marketing and Authorization Applications for Regulatory Affairs

    

TURKREACH (KKDIK) Consulting and Advisory Registration Technical Services Trainings

The assistance we can provide for TURKREACH Regulation KKDIK includes but is not limited to: –Regulatory strategy and advice –Programme and project management –Pre-SIEF application and management for TURKREACH –SIEF and consortia management – SIEF Formation Facilitator services and full SIEF/consortium management or participation –Data evaluation and gap analysis – determination of availability of data held by a company and in the public domain and evaluation of their suitability , review of data within the SIEF, literature searches and identification of data gaps –Use of Intelligent Testing Strategies (ITS) – identification of data gaps, consideration of grouping and read across, exposure and technical data waivers, expert statements and QSAR modelling –Study placement and monitoring –Dossier preparation and submission – complete dossier in KKS system for TURKREACH including robust and end point study summaries, enquiry dossiers, testing proposals, classification and labelling and toxicokinetics assessment –Chemical safety assessments/reports – identification of uses and exposure routes, hazard assessment, DNEL/PNEC derivation, PBT/vPvB assessment, exposure assessment and development of exposure scenarios, risk characterisation and recommendations on risk management measures –Evaluation and authorisation services – post submission, support, negotiation with TR Chemical Help Desk of MoEU, applications for authorisation and socio-economic analysis –Only Representative and Third Party Representative services

    

Environmental Risk Management Green Chemicals Management Carbon footprint Eco friendly final products Enviromental Regulatory Compliance

Environmental Risk Management Identifying and Understanding Environmental Risks and Liabilities is a must especially for Chemical Companies. Understanding these makes it possible to safeguard against and manage these risks and liabilities.

The Doruk Sistem Environmental Risk Management service encompass determining prevailing current and estimating futures Environmental Risks and Liabilities and recommending a strategy for managing these risks.

Energy Efficiency Services Doruk Sistem provides solutions for developing organisation wide energy efficiency programs to: • Decrease the corporate carbon footprint, • Conserve energy, • Measuring energy efficiency performance.

Furthermore, Doruk Sistem supports in implementing actual energy efficiency measures with proper tools for monitoring performances.

    

Responsible Person Technical Dossier Preperation Safety Assestment Consultancy Bespoke formulation

We offer the following services to our corporate clients: • • • • • • • • •

Safety Assessment / Toxicology Report Product Information File assessment and creation Fragrance Allergen declaration EU and TR Labelling and packaging compliance Consultancy in all areas of EU and TR cosmetic laws GMP Consultancy and Audit Bespoke Product Formulation and Manufacturing Responsible Person Services Notification Services

Current clients include both SME and major manufacturers and suppliers from within and outside the EU.

    

Certification Consultancy Risk Management Auditing Evaluation Inspection

We offer the following consulting and advisory services to our corporate clients: • • • • • • • • • •

Regulatory Compliance Consultancy Quality Management System (ISO 9001) Environmental Management System (ISO 14001) Occupational Health and Safety Management System (OHSAS 18001) Risk Management Profiling and Policy Development Quality Assurance Chemical Safety Management Auditing Inspection Advisory

   

We offer the following consulting and advisory services to our corporate clients: • • • • • •

Workplace Risk Assessments Corporate Health and Safety Audit Health and Safety Support Service – Navigator Task and Staff Risk Assessments Regulatory advice Industrial Hygiene

We can also liaise with enforcing authorities, bespoke solutions for your business comprising: • • • • •

Initial health and safety consultant’s diagnostic visit Comprehensive documentation and handbooks Implementation and training Further visits to review compliance Regular support and advice

Risk Assestment Auditing Evaluation Regulatory Advice

    

Safety Data Sheet Extended SDS , Exposure Scenerio SDS Software CLP Compilation Label Validation

Doruksistem is leader in delivering high quality, complianced Safety Data Sheets (MSDS) authoring, compilation and technical translations in Turkey.

Over 45000 SDSs are prepared last 10 years.

We are committed to providing our clients with first rate services, regardless of the regulatory challenge.

DORUKSISTEM Authoring/Writing Service assists companies in Authoring/creating, auditing, writing and updating SDS, extended SDS, Exposure Scenerio, CLP Classification Our Technical ‘CERTIFIED’ expert staff has created more than thousands of SDS sheets for both internal purposes and as consultants to our customers.

Please visit our web page now.

www.msds.com.tr

Some of our traing topics are as follows: • EU and TR Chemical Regulatory Compliance • TURKREACH KKDIK Regulation • Approved ‘Chemical Assessment Specialist Training Center According to TURKREACH KKDIK Annex-18 • EU REACH Regulations • Safety Data Sheet (Approved & Certified Expert Courses) • CLP/GHS Classifications • Cosmetics Regulations (SA and SE management) • GMP and GLP • Chemical Safety Assestment • Biocidal Products Regulations • Waste Management • Work Place Health and Safety • DG Goods Transportation and Classification • Hazardous Chemicals Classification • SEVESO - COMAH Regulation Compliance Topics • Risk Analysis Methods in Proses Safety • Risk Analysis Software Trainings, (HAZOP, BowTie, Consequence Modelling, Risk Frequency Analysis etc) • SDS Software trainings • Chemical Risk Management • More and more in Doruk Sistem Academy

      

Seminars Webinars Courses Workshops Inhouse trainings SDS Expert Certification Ministry Approved Trainings in TURKREACH

       

Pharmaceuticals Chemicals Agrochemicals Biocides Medical Devices Cosmetics Food REACH    

SVHC, ROHS, WEEE POHS and more

DIN EN ISO / IEC 17025 Technical Competence, Biocompatibility tests and Microbiological tests for Medical Devices GMP Safety, Conformity with Specifications, Microbiological tests and Bioassays in vitro / in vivo for pharmaceuticals / biologics GLP Traceability, Toxicology, Pharmacology in vitro / in vivo, Pharmacocinetics, ADME, Analytics, Microbiological tests and Bioassays in vitro / in vivo for pharmaceuticals / biologics FDA Our Partner Laboratory was inspected by the US Food and Drug Administration successfully in July 2006 and 2011.

We support our clients in protecting the health and safety of man and the environment.

Our customers are industrial enterprises that represent the chemical, pharmaceutical, automotive, electronics, manufacturing and retail industries, to name but a few.

Our solutions include software, process expertise, implementation services, regulatory content and managed services.

ADVANTAGES OF COLLABORATION WITH DORUKSISTEM

 Communication channels with Turkish Ministries and Municipalities.  Follow up of Turkish and EU regulations about chemical industry and environment relations.  Follow up updated technologies about chemical compliance and environmental services.  Networking with industry associations to forecast their needs.  Better understanding of global expertise, served in local philosophy.  Experienced, well organized, certified team.

Doruk Sistem works with

TSE & TURKAK certificated experts

to manage TURKREACH KKDIK process as CAS – KDU and to author and compile legal Safety Data Sheets

Our Team

Our International Presentations

Doruk Sistem is an

ISO 9001:2015 awarded Company

Doruk Sistem is the only associated member to ORO – Only Representative Organisation outside from EU

Our Partners and Collaborations Organisatons,Universities

Middle East Technical University

And more ‌

SOME OF OUR INTERNATIONAL CLIENTs

And more …

www. turkreach.com.tr

Visit us now at www.turkreach. com.tr or www.kkdik.eu

www.doruksistem.com.tr

Visit us now at www.doruksistem.com.tr

when Quality is your Priority

Our Code of Conduct  We establish and consolidate trust-based relationship with our clients.  We work together and think over the way we work.  We operate with policy “win-win”, delivering results for clients and achieving profitable growth.  We offer only those services we can deliver and strive to deliver no less than our commitments.  We meet our contractual obligations and report and charge honestly for our services.  We compete vigorously, solving our client’s problem with diligence and intelligence.  We intend to achieve excellence on every case and build long-term relationship with our clients.

Our Performance Values  We are customized, willingly working with our clients and tailoring solutions to their specific needs.  We demonstrate integrity, build credibility.  We respect our clients, and also respect our colleagues.  We obey the code of ethics, respecting the confidentiality and privacy of our clients.  We uphold our clients’ reputations as well as our own.  We achieve excellence through innovation, learning and agility.

when Quality is your Priority

"Your partner in Turkey" Our ÂŤOnly RepresentativeÂť services include; TURKREACK KKDIK Full Compliance and Consultancy, Dossier Preparation, Crossword translation from IUCLID To KKS, CSR,CSA Preparation with certified specialists, SIEF/CONSORTIA (including LR, SFF, LoA, etc.) Management, (e)SDS Authoring, Compilation & Management, TURK CLP (SEA) registrations, Licensing for Biocidals, Plant Protection Products, Cosmetics, Pesticides, etc., Chemical Management System Solutions and all other related regulatory compliance topics you needed.

info@doruksistem.com.tr