Regulatory support

Regulatory Support

As a CDMO involved in the manufacture of RSMs and APIs, Angelini Fine Chemicals constantly reviews regulatory developments in all relevant pharmaceutical markets to keep you one step ahead – today and tomorrow.

Concurrently with the API chemical development, Angelini QA & RA personnel routinely collaborate with the Customers to provide technical and regulatory services to support all stages of product development, registration and market launch.

Angelini’s Regulatory Affairs group works closely with R&D, Manufacturing and QA/QC to compile and prepare high quality technical dossiers (DMFs, CEPs, etc.) to support a smooth and fast registration of the Drug Substances with Health Authorities Worldwide (AIFA, FDA, PMDA, ANVISA etc.) in accordance with the current legislation and guidelines.