Dossier Services
Compilation of dossier as per latest country specific guidelines.

Dossier compilation as per :

  • Common Technical Dossier (CTD) Guidelines.
  • Asean Common Technical Dossier (ACTD) Guidelines.
  • Country Specific.

Dossiers compilation for submissions in :

  • Asia
  • Africa
  • Central America
  • South America
  • North America

Drafts data for :

  • BMR, MFR
  • Process Validation,
  • Analytical Validation,
  • Stability Study reports,
  • Dissolution profile,
  • Certificate of analysis and related reports

Reports on :

  • Bioavailability / Bioequivalance Studies,
  • Clinical Trials studies
  • Justification for fixed dose combination
  • Prepare Periodic Safety Update report(PSUR)
  • Preclinical studies like Toxicity, Subacute, Acute, Carcinogenicity, Teratology and Reproduction toxicity.

Prepare Summary of product (SPC), Pack Insert, Product Rationale :


Expert Reports :

  • Quality,
  • Pre-clinical,
  • Clinical

Overviews (Module 2) :

  • Clinical
  • Non-Clinical

Nonclinical Study Reports (Module 4) :


Clinical Study Reports (Module 5) :


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