REGULATORY AFFAIRS SERVICES PIONEERS IN PHARMA REGULATORY
& CLINICAL SERVICES
It is recognised that the pharma industry in India is among the most stringently regulated; and the regulations that reinforce this status are necessarily complex and multilayered. For any organisation attempting to steer itself through the regulatory path, from concept to a nal product approval, the most obvious and cost-effective solution is to work with CliniExperts who are able to manage the entire process.The team at CliniExperts has in-depth, and up-todate, knowledge of the laws and regulations pertaining to the development, testing, approval, manufacturing, commercialisation and post-marking surveillance of pharmaceutical, biopharmaceutical and medical device products. Staffed by doctors, graduates and masters in pharmacology, we distinguish ourselves from our contemporaries by virtue of our proven ability to handle all regulatory projects in a highly competent manner. And we guarantee complete and awless product dossiers in Common Technical Dossier (CTD) format, Asean Common Technical Dossier (ACTD) format, or to any latest countryspeci c format.
SERVICES Services offered for regulatory consultation by cliniexperts
Our technical and liaison team provide regulatory assistance at Global, Indian Central, Zonal & state level.
Indian Central SERVICES AT CDSCO We focus to acquire speedy regulatory approval for client to conduct clinical trials, covering new drugs, FDCs, investigation drugs, biological products (vaccines, peptides, recombinant products, stem cells, etc.), or devices.
The CliniExperts Differentiators We enjoy excellent professional relations with the regulatory bodies of India and at US-FDA. Our regulatory services team is led by medical and pharmacology experts who perform scienti c reviews of the protocol and the Investigator's Brochure (IB), and guide the team to prepare a dossier that avoids ambiguity or query generation. We can represent the client at the Central Drugs Standard Control Organisation (CDSCO), Food Safety Standard Authority of India (FSSAI), Indian Council of Medical Research (ICMR) and other government bodies and can discuss the product development strategy. We have particular expertise in the designing of a strategy, and in the gathering of approvals at the earliest from DCGI. We provide NDAC meeting support to our clients. We are based in New Delhi and this gives us the advantage of being in close We are based in New Delhi and this gives us the advantage of being in close proximity to the of ce of all central government regulators involved product approvals: Central Drugs Standard Control Organisation (CDSCO) Food Safety and Standards Authority of India (FSSAI) Indian Council of Medical Research (ICMR )
Global Clinical Trials Regulatory permission for Phase I, II and III clinical trials Import/export licence approval from DCGI Approvals, Noti cations or No-objections for Protocol Amendments Noti cations of documents such as ICF, SAEs, etc. We provide NDAC meeting support to our clients.
New Drug Approval We offer a one-stop solution for formulations, API, FDCs, new indication, new dosage form, modi ed release dosage form, ayurvedic, Neutraceuticals, veterinary and cosmetics. We also provide toxicology study services: Acute Toxicity Sub-chronic Toxicity Chronic Toxicity / Carcinogenicity Teratology Studies, etc. We provide all the technical support along with it we can assist pharma companies in sample analysis, testing and certi cation from CDL, CIPL and CDTL.
Licences and Registration Manufacturing We can assist in obtaining a manufacturing licence for LVP/Vaccine/SERA in collaboration with CLAA, State FDA and Zonal of ces. Import (Form 10) We can assist in obtaining import licences for Bulk drug & nished formulations Biologicals Medical devices Diagnostic kits (both critical and non-critical) Cosmetics Registration On your behalf, we can register the following products at CDSCO: Bulk drug & nished formulations Biologicals Medical devices & critical diagnostic kits Cosmetics
Test Licence We can obtain a test licence for all kinds and classi cations of products.
Global Regulatory Services
Narcotics We assist in obtaining an Export No Objection Certi cate (NOC) for Narcotics.
REGULATORY CONSULTING AT US-FDA
Embassy Attestation We can arrange the Ministry of External Affairs Embassy attestation and subsistent Embassy Attestation for relevant countries.
Academic Trial Approval We offer the service to speedily obtain approval for the commencement and undertaking of an Academic Trial in India.
SERVICES AT ICMR Dossier and application submissions for research projects involving foreign assistance and/or collaboration in biomedical/health research, submitted by the Indian investigators to ICMR for approval through the Health Ministry s Screening Committee (HMSC). Lodge and secure approvals by the ICMR for the import of human and biological samples.
SERVICES AT FSSAI FOR FBO The Food Safety and Standards Authority of India (FSSAI) has recently amended its regulations. CliniExperts can assist FBOs in obtaining following approvals from FSSAI, New Delhi.
Submitting and obtaining approval, PFA conversion, by the FSSAI for a new product/ Nutraceuticals
Drug & Medical Device Regulatory Consulting CliniExperts have aligned themselves with the internationally renowned regulatory consulting company SRC (http://srcteam.com/). SRC has a proven track record in drug, medical device, and regulatory consulting and has been providing services since 1987. Their experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines and recommend the right course of action for an organisation. SRC is positioned to act as Regulatory Department on an as needed basis, offering signi cant cost savings. SRC regulatory consulting services include: Regulatory strategic planning from design to market (Fast Track, orphan drug, drug vs. cosmetic, etc.), Product Classi cation Review (devices, drugs, combination products), FDA meeting management for key milestone meetings with regulatory agencies (Pre-IND, Pre-IDE, End Phase 2, etc.), Medical devices regulatory support for 510(k), IDE and PMA, OTC drugs: Rx-to-OTC switch, Time and Extent Application, US agent status for non-US companies.
Obtaining central license from FSSAI Submitting and obtaining licenses and registration from the FSSAI for food business operators wishing to trade in India.
Zonal and State Level
We employ a network of specialists who are able to assist in obtaining any of the licenses or NOCs issued by the state or zonal authorities in India.
Form 29 Export NOC Dual Use Manufacturing License Wholesale License Food License Various Authorization for Interstate Import/Export
Global Licensing & Registration We are fully experienced, and have specialised skills in providing assistance to international pharma companies who want to register their products in the USA and the European Union. We are also highly adept at managing the registration process for other countries in Europe, Africa, Asia, the Middle East and South America. We work closely with the highly respected US regulatory consultancy, Strategic Regulatory Consulting. The CliniExperts team can advise and develop all relevant dossiers that meet speci c ACTD, EU CTD, eCTD requirements pertaining to all the scienti c disciplines required for successful registration of products in Asian countries, the European Union, and all other countries.
PRODUCT REGISTRATION At CliniExperts, we measure our success by the time it takes to secure a product registration through the appropriate regulatory authorities. In this we have an enviable reputation for ef ciency and competence. Initially, we ensure that all data provided by our clients is carefully scrutinised to ensure its adequacy and accuracy. We can guide and advise our clients beforehand so that the submitted data fully meets the requirements for product registration, and eliminates any risk of delay. We also conduct an independent review of the available data to ensure that any potential de ciencies are identi ed beforehand and corrected during the dossier development process. For each task, a technical specialist is allocated - either from our in-house team, or from a specialised subcontractor - to ensure ef cient project management. A project milestone plan is created and communicated to the client and when the client is satis ed with the logic and timings of the draft plan, the project is initiated for subsequent delivery on time. A detailed regulatory submission strategy is developed and the dossier documents pertaining to product registration are prepared in sync with the regulations and guidelines of concerned countries. All appropriate information required by the regulatory authority in terms of quality of the product, safety, ef cacy, analytical data, validation protocol, etc. is addressed effectively. Once the data submitted is accepted by the relevant regulatory authority, the product registration takes place in a timely manner. In the event of a query being raised by the authority, a scienti c, robust response is presented and the process of obtaining the product registration is expedited. CliniExperts can assist companies seeking to get their products added to the WHO list of prequali ed medicines. Our GMP auditors can visit your facility to check compliance with WHO GMP and/or conduct a preparatory GMP audit prior to WHO inspection.
Our comprehensive WHO prequali cation audit service will: Ensure that all relevant documents are prepared in accordance with the requirements, Gather all speci c product details, site details, and all other relevant information, Assist in compiling a product dossier - following up any issues identi ed and streamlining all raw data into CTD module-speci c categories, Submit the product dossier to the WHO in Geneva, Switzerland, Provide full administrative, technical and scienti c assistance until prequali cation is achieved.
PIONEERS IN PHARMA REGULATORY
& CLINICAL SERVICES
New Delhi Unit -816, WestEnd Mall, Janakpuri, New Delhi -110058 Ph: +011-45024269, +91-9811273023, 9999219448 Email : contact@cliniexperts.com www.cliniexperts.com
Mumbai Chincholi Bunder Road Malad West, Mumbai- 400064 Maharashtra Ph: +91-9819441499