Regulatory Affairs2019-04-29T23:33:15+00:00

Regulatory Affairs

Life Cycle Management Promotional Activities Translation & Revision

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 and food supplements and introduce these products on the market, making sure to be compliant with European and national legislations and guidelines.

We present hereafter a non-exhaustive list of tasks we offer:

MEDICINAL PRODUCTS

  • Preparation, compilation to eCTD, submission, follow-up and maintenance of marketing authorisation applications, variations, renewals
  • (Export) declarations, free sales certificates
  • Preparation, submission, follow-up of clinical trial applications (CTA), amendments, notifications, declarations according to Vol 10
  • Data evaluation and strategic advice
  • Expert report/summary writing (analytical, toxicological, clinical)

FOOD SUPPLEMENTS

  • Preparation, submission and follow-up of notifications to HA via FOODSUP

RAW MATERIALS

  • Preparation, submission, follow-up and maintenance of licences

GENERAL

  • RA advice
  • Local interface between the client and the local competent authorities
  • Revision of artwork
  • Preparation market access