CARBOGEN AMCIS supports customers through the complex process of setting up a CMC regulatory strategy for drug substance and drug product development as well as during lifecycle.

Our highly experienced CMC Regulatory Affairs group works alongside the development and production departments to ensure that the regulatory requirements of all regions are adhered to. Our experts are well-versed across the international markets and specific regional requirements and fully understand the expectations of different jurisdictions.

The critical role that our Regulatory Affairs department plays in the route from concept to market is underlined by the vast wealth of experience and knowledge of our experts. We support APIs through development, registration and the post-approval lifecycle, as well as Antibody Drug Conjugates (ADCs) and drug products in development. The Regulatory Affairs team is acting as your Regulatory contact, working in close collaboration with you, the R&D specialists, analytical and production departments to develop phase-appropriate CMC Regulatory strategy and documentation.