Regulatory Services

Our Regulatory Affairs team has an important role in any project during all the lifecycle, in order to prepare and deliver the necessary registration documentation for the intermediates and APIs for submission to the regulatory authorities (US Food and Drug Administration (FDA), European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Japan PMDA, China FDA (CFDA)…)

We prepare and deliver the necessary registered documentation for active pharmaceuticals ingredients (APIs) and intermediates for submission according to the guidelines:

  • Drug Master Files for the EU, USA, Japan, China as well as other worldwide markets
  • Complete CMC documentation (Module 3.2.S) for approval applications
  • EP-Certificates of Suitability (CEP)
  • Notifications of change
  • Assessment reports according to ICH Guidelines (genotoxic and mutagenic assessment, elemental impurities, residual solvents…)