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Regulatory Affairs

CDMO Regulatory support and services

Your one-stop shop for CMC Dossier and Regulatory Affairs services

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.

From clinical trial applications (IND/IMPD), through global Marketing Authorizations (MAA, NDA, BLA) to post-approval marketing lifecycle management of commercial APIs and Drug Products, the Regulatory Affairs group has developed CMC regulatory strategies for a large number of successful submissions.

Experts in CMC Strategy & Regulatory Documentation

  • CMC support for NDA, MAA, BLA, IND & IMPD, including phase-appropriate regulatory reviews of CMC documentation
  • Multiple Drug Master Files (e.g., US-DMF, EU-ASMF, Japanese, Chinese, Indian & Brazilian Master Files)
  • CEP (Certificate of Suitability to European Pharmacopoeia)
  • Post-Approval Change Documentation

The API portfolio of CARBOGEN AMCIS presents a fascinating diversity of regulatory scenarios – from long time registered, to clinical development, to complex structure APIs. My mission is to help customers navigate Regulatory processes with a tailored approach and bringing medication to patients as soon as possible.

Elisabeth - Head of Regulatory Affairs, Bubendorf

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