Our experienced team is qualified to advise on all the scientific disciplines required for successful registration and maintenance of a Marketing Authorisation.
National Member State and European law states that all medicinal product Marketing Authorisations must be continually reviewed and kept up-to-date. TRAC can maintain your product by conducting license transfers, variations, renewal applications and Periodic Safety Update Reports (for more information visit our Pharmacovigilance page) to ensure that your product continues to meet the necessary standards of safety, efficacy and quality.
TRAC has extensive experience in Chemistry, Manufacturing and Controls (CMC) and can confidently undertake your project. We have professionals adept at processing compliance and manufacturing source transfers accurately and efficiently. We also have experts in variations who have vast experience processing all Type IA and IB and Type II variations successfully including line extensions.
TRAC is also highly skilled in the area of the reclassification of medicines and we can quickly and accurately process your reclassification either from Prescription Only Medicine (POM) to Pharmacist (P) or to General Sales License (GSL).
Our professional individuals are also able to assist on changing of ownership, RA Documentation review and improvement and labeling updates.
If you have any further questions regarding license or marketing authorisations download our free guide to obtaining Marketing Authorisations. Or 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.
