DOSSIER SUPPORT

Manufacturer: Afra Pharma Consultant
Price: ------
Product Code: ------
City Pune
State Maharashtra
Country India

Payment Terms

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Member StatusPremium

Product Description

OUR COMPILATION OF DOSSIER AS PER LATEST COUNTRY SPECIFIC GUIDELINES

Dossier compilation as per:

  • ASEAN Common Technical Dossier (ACTD) Guidelines
  • South Africa (MCC-MRF-1) Guidelines
  • Brazil ANVISA Guidelines
  • G.C.C countries

Dossiers (CTD) compilation for submissions in:

  • Asia
  • Africa
  • Middle East
  • Central America
  • South America
  • North America

Dossier compilation in Common Technical Dossier (CTD) format and Conversion to eCTD for:

  • US FDA
  • Saudi FDA
  • European counties

DMF (Drug Master File):
We have associated with NABL Certified well established labs to carry out analytical testing.

We also perform the following studies, in co-operations to DMF preparation:

  • Structural Elucidation Studies
  • Analytical Report (COA)
  • Analytical Method Validation
  • Process Validation
  • Stability data studies
  • Determination & Validation of Potential Impurities & Solvent Impurities

(All the data supported by necessary Chromatograms & Spectrums)

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