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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