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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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 We have excellent contacts all over the 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 help overseas buyers for contract manufacture of various products on exclusive basis by using technical talent and expertise available with Indian manufacturers.
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.
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| Liaison Services |
| Liasoning work for international pharmaceutical companies in India to: |
- Identify loan licence / third party manufacturers in India.
- Take care of local licencing formalities.
- Liaise with the Drug Controller General’s office for obtaining Marketing Authorization for new drugs.
- Organize clinical trials and BE studies on behalf of clients.
- Labela will take care on the supply side, see that products are supplied in time as per contract satisfying
all conditions.
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