Mike is a highly experienced professional with over 20 years of expertise in the pharmaceutical and biopharmaceutical industry. He brings a wealth of knowledge and skills to assist clients in navigating the complex regulatory landscape. Mike specializes in authoring and reviewing CMC submissions, ensuring compliance with regulatory requirements from IND through NDA. He also provides valuable support in managing submissions, streamlining processes, and ensuring timely regulatory approvals.
Key areas of expertise
- Highly skilled at preparing CMC applications and agency responses to CMC information requests
- Performing pre-NDA gap assessments against FDA and ICH requirements
- Preparing Pre-IND meeting requests and briefing books
- Preparing and maintaining Type II biologic master files
- Post-approval lifecycle maintenance for the US and global markets, and obtaining global marketing authorizations following FDA and EMA approvals
Before NDA
Mike has experience in Quality Assurance, where he was responsible for batch release and deviation / CAPA resolution for a commercial biologics manufacturing company. Mike began his CMC Regulatory Affairs journey at a midsize, rare disease company, obtaining approvals for marketing applications and post-approval changes in the Asia-Pacific and Latin America regions. He was the Regulatory CMC lead for an enzyme replacement therapy that obtained marketing approval in China. Subsequently, he consulted for sponsor and CDMO companies.
Mike Cooper