The Chemistry, Manufacturing and Controls (CMC) landscape is undergoing rapid change. Manufacturing processes are evolving, the marketplace is growing, gaining foothold in the US as well as the existing EU landscape, and vaccines are surging. Having an effective CMC regulatory compliance strategy in place to meet EMA and FDA requirements is critical. Understanding the CMC requirements right across every stage of development, from successful clinical trials, to approval, on the market and future patient safety are paramount. Getting this wrong can lead detrimental market approval delays.
NDA has a team of former regulators and scientists that have indepth experience and hands-on expertise of CMC regulatory standards and development priorities for small molecules and complex biopharmaceutical products. We understand the intricacies of how manufacturing processes and product quality control is interfaced with knowledge of regulatory requirements for building a successful development strategy from the lead candidate selection stage onwards. Unrivalled experience and knowledge of EU regulatory practices enables NDA to provide in-depth analyses that correspond to the actual standards that will be applied during the preparation and review of clinical trial applications and MAA dossiers.
Our track record
NDA has managed the successful delivery of more than ten EU Marketing Authorisation Applications, just over the last two years. In addition we supported close to 100 additional major submissions over the past five years, including NCEs, line extensions and major post-authorisation variations. Our track record is unmatched in industry with over 40% of products recommended for approval in the EU between 2013-2016 being supported by NDA.
How we help
NDA can guide you through the complete CMC development programme, from the clinical development phase, through to authorisation and post-approval. This includes strategic development planning and strategy for all types of molecules and pharmaceutical dosage forms to support global registration, all manufacturing requirements, comparability studies, through to post-authorisation support for product maintenance.