Zwiers experts are able to support your CMC-RA needs throughout the whole life cycle of your product from development to MAA/BLA submission, into the market and post approval

• The best regulatory strategy to develop and market your product that meets patients’ needs
• Support to apply the complex and large number of regulatory guidance and regulations
• Support for health authority scientific advice requests
• GAP analyses of existing documents and strategy support, e.g. for stability studies, specifications setting and process validation control strategies
• Scientific writing of CMC development documentation, Investigational Medicinal Product Dossier (IMPD)/Investigational New Drug (IND) for Clinical trial applications (CTAs) and eCTD Module 2 and 3 for MAA/BLA applications
• Support for Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) and Drug Master File (DMF) documentation and procedures
• Risk assessments and documentation requirements for submission package requirements such as nitrosamine statements, letters of authorisation (LOA), TSE/BSE certificates
• Post approval/life cycle management of CMC country specific submissions including variation submission strategies and change management protocols

Strategy, accuracy and quality are key in CMC! Our experts are aware and able to deliver.

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