Regulatory Compliance

IPM helps client in regulatory compliance of API & Formulation for regulated and emerging markets. We assist in registration services with various regulatory agencies wrt the following:

  • Drug substances/Bulk drugs and intermediates [Regulated & Emerging markets]
  • Drug products [Regulated markets & Emerging markets]
  • Drug substances/Bulk drugs and intermediates
    • Preparation and submission of DMF [USDMF, ASMF] to regulatory agencies
    • Gap analysis of ready DMF
    • Handling deficiencies
    • Preparation and Submission of CEP dossier
    • Genotoxicity study report
    • Life cycle management [Annual updates, amendments, revision-renewal]
  • Drug products [Emerging markets- Asia, Africa, Latin America, Central America and CIS countries]
    • Dossier writing
    • ICH CTD, ASEAN CTD and country specific formats
    • Prepare documents for Company registrations in various countries
    • Convert ICH CTD dossiers to ASEAN CTD dossier
    • Review, evaluation and Gap Analysis for compiled dossiers
    • Respond to deficiencies raised by regulatory authorities
    • Renewal of registrations
    • Prepare documents to file variations in case of registered products
    • File GMP applications to arrange GMP inspections
    • Prepare /review Site Master File
    • Prepare SMPC/ PIL/ text for artworks
    • Quality Overall Summary
  • Drug products [ANDA submissions ]
    • Gap Analysis of ready dossier
    • Module 1: Preparation of Administrative and prescribing information
    • Module 2: Summaries and overviews by expert for Quality, Clinical and nonclinical
    • Module 3, 4 and 5: Dossier writing
    • Compilation of CTD modules in eCTD format
    • Structured product labeling (SPL)
    • Response to deficiencies
  • Drug products/Formulation [Eu submissions ]
    • Gap Analysis of ready dossier
    • Dossier writing for MAA
    • Summary writing for Module 2
    • Literature references for Module 4 and Module 5
    • Conversion of CTD or NeeS format to eCTD
    • Preparation of SmPC, PIL
    • Response to deficiencies
Ms-anghana