Regulatory Services

REGULATORY SERVICES

Propharmex offers wide range of regulatory services right from the beginning of drug product development till marketing authorization and product life cycle management.

  • Dossier compilation as per eCTD for regulated markets, and country specific guidelines / formats (ROW) for different dosage forms.
  • Review of dossiers for country specific filing.
  • Dossier due diligence and Bridging studies for market extension of approved dossiers./products.
  • Provide support in responding to queries from Regulatory Agencies.
  • Provide complete stability programme management services as per ICH guidelines.