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.