Regulatory Affairs Services

Pharmassist provides a wide range of regulatory affairs services.

We offer scientific, legal and strategic advice for the development, manufacturing, licensing, marketing and compliance of medicinal products with current local and EU regulations. Further Pharmassist services include the collection of technical data and scientific writing of chemical and pharmaceutical documentation, for example preparation of registration dossiers in CTD, NeeS and eCTD format for national, MR and DC procedures.

We also offer coordination and execution of all activities pertaining to the registration and maintenance of marketing authorisations of medicinal products, food supplements, medical devices, cosmetics and biocides, as well as accurate translations of scientific documents (SPCs, PILs and training material).