Life cycle management

Back to Regulatory Affairs

InfarAMA offers a wide range of regulatory services in BENELUX, as well as other EU countries, and helps you to obtain and maintain your regulatory licences for medicinal products, medical devices, raw materials and food supplements.

This is a non-exhaustive list of services we offer :

  • Ad hoc RA advice

  • Be your local interface with the local competent authorities

  • Data evaluation

  • Guidance with strategic RA advice

  • Medical writing

  • Preparation, submission, follow up and maintenance of marketing authorisation applications

  • Variations, renewals for medicinal products

  • Preparation, submission, follow up and maintenance of your files

  • Revision of artwork