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 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