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.