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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Headquartered in Mumbai, India, Labela Regsources, is a provider of complete solution on Regulatory Affairs to Pharmaceutical companies wanting to introduce products into global markets. Established in 1997, the company is headed by Rita Gada, a pharmacist with over 19 years of experience in the field of Global Regulatory Affairs. The team at Labela consists of well qualified and dedicated staff with rich experience of dossier compilation and regulatory filings across global drug authorities.
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