Transfer of marketing authorisation
Navigating the transfer regulatory procedure for biopharma
Mergers, acquisitions, spin-offs, and similar activities play a crucial role in the growth strategies of most biopharmaceutical companies. As a result, authorised medical products are almost always transferred to a new company, but the process is not automatic.
A successful MAT application is a very complex and cross-functional activity, involving many steps that require insightful planning and execution. Good teamwork, planning, and communication between all stakeholders including any clinical research organisations (CRO) that work for the seller or buyer are critical success factors.
Read the whitepaper for best practices and clear guidance on transferring medical products, including:
- The importance of early regulatory and cross-functional readiness when planning the transfer of an approved medicinal product
- The MAT regulatory application process for major markets, including the EU, UK, Switzerland, Canada, and the United States