We are able to use our professional knowledge and experience to apply for Marketing Authorisation Applications (MAA) on your behalf. Our employees have extensive experience in generating Marketing Authorisation Applications ensuring that all applications are created accurately and on time.
TRAC have experience of all current European routes available to gain Marketing Authorisation for pharmaceutical products including National, Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and the Centralised Procedure (CP). The majority of our applications are submitted through Non-eCTD electronic Submissions (NeeS) or Electronic Common Technical Document (eCTD) the new and preferred format.
We also have a wealth of experience in Post Marketing Authorisation Maintenance, maintaining your product by conducting license transfers, variations, renewal applications and Periodic Safety Update Reports (PSURs) to ensure that your product continues to meet the necessary standards of safety, efficacy and quality.
Download our free guide to obtaining Marketing Authorisations for your products. This document will help you understand the various routes to market that are available and decide what the best option for your product is. If you have any further questions regarding Marketing Authorisation Applications please Contact Us or complete and submit an Enquiry Form.
Guide: Obtaining Marketing Authorisations
This guide, as well as other information can be downloaded from our download centre.
