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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Labela’s International regulatory Consultants can provide export advice to your business needs and can manage a complete foreign marketing arm for your company for Regulatory affairs.
