Our Services
Lifecycle maintenance: variations (Type IA, IB, II), renewal, and MA transfer, ‘sunset clause’ exemptions package, withdrawal
Lifecycle maintenance: variations (Type IA, IB, II), renewal, and MA transfer, ‘sunset clause’ exemptions package, withdrawal
Lifecycle maintenance: variations (Type IA, IB, II), renewal, and MA transfer, ‘sunset clause’ exemptions package, withdrawal
We provide regulatory support throughout the lifecycle of products. Many variations are required to keep the dossier up to date during the lifecycle of a medicinal product. Our services are customized to your needs and cover all aspects of lifecycle management like preparing variations, managing MA renewals, sunset clauses and withdrawals.