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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