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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.