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Compilation of dossier as per latest country specific guidelines
Ω Dossier compilation as per :
• Asean Common Technical Dossier (ACTD) Guidelines.
• South Africa (MCC-MRF-1) Guidelines.
• Brazil ANVISA Guidelines.
Ω Dossiers compilation for submissions in :
• Asia
• Africa
• Central America
• South America
• North America
Ω Dossier compilation in Common Technical Dossier (CTD) format for
• Commonwealth of Independent States
(CIS) Guidelines.
• South East / West Europe Guidelines.
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Ω Drug master file (DMF) compilation for open and closed parts
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Ω Drafts data for
• BMR, MFR
• Process Validation,
• Stability Study reports,
• Dissolution profile,
• Certificate of analysis and related reports
Ω Reports on
• Bioavailability / Bioequivalance Studies,
•
Clinical Trials studies
• Justification for fixed dose combination
• Prepare Periodic Safety Update report (PSUR).
• Preclinical studies like Toxicity, Carcinogenicity, Teratology & Reproduction toxicity.
Ω Prepare Summary of product (SPC), Pack Insert, Product rationale.
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Ø Expert Reports
• Quality,
• Pre-clinical,
• Clinical
Ø Overviews (Module 2)
• Clinical
• Non-Clinical
Ø Nonclinical Study Reports(Module 4)
Ø Clinical Study Reports(Module 5)
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Ω Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.
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Ω Dossier conversion (from one country to another)
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Ω Registration Assistance
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Ω Labela Regsources has a specialized division that helps medical device manufacturers research, analyze, select & manage Indian medical device distributors.
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 Our focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. We are have been involved with all aspects of regulatory affairs, from supporting Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier / application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry. We also offer ‘Gap Analysis’ which is a meticulous review of the dossier ready for submission.
We have rich experience of providing services across therapeutic segments (including animal health and herbal products) and have registered more than 5000 products in over 100 countries for more than 500 pharmaceutical companies.
We have excellent contacts all over India and therefore we also provide liaison services for those who wish  to search for suppliers of raw materials, products and processes, as well as for those who wish to expand their global presence in a very telling manner. Business consultancy is provided on various aspects related to imports, exports, regulations, market conditions, competition, product viability, etc.
We are well equipped to meet all your other requirements like Drug Formulation & Bulk Drug API’s, Machinery, Chemicals, Instruments, Paramedical, Herbal Phytochemicals and Neutraceuticals, etc. from any part of India.
 We help overseas buyers for contract manufacture of various products on exclusive basis by using technical talent and expertise available with Indian manufacturers.
We have a specialized division that helps medical device manufacturers research, analyze, select and manage Indian medical device distributors. With a team of experienced professionals on-site Indian we can help you obtain fast and cost effective access to the Indian market. We take a multi-faceted approach to medical device distribution management. The goal is to ensure that all potential medical distribution partners in India are objectively evaluated, based on your business needs, and carefully monitored afterwards for ongoing success.
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