Considerable time and costs are associated with MA applications so it’s vital to choose the optimal application route and have dossiers that are accurate and compliant before submission to the Regulatory Agencies. The route we help you take will depend on your products’ active ingredient, your intended market and the regulatory strategy.
With experience across all four routes, TRAC provides regulatory support and guidance throughout the application’s lifespan. We can compile and submit dossiers in either eCTD or NeeS format and, as well as getting your product to market as efficiently as possible, we work hard to ensure it stays there.
TRAC also undertakes user testing:
User testing (or readability testing) has been a mandatory requirement for EU applications since 2005 (Directive 2004/27/EC). Its aim is to improve the understanding and safety standards of patient information leaflets by encapsulating the results of consultations with target patient groups.
We can provide a complete user testing service which includes:
- expert advice on PIL design, format and structure
- PIL writing and editing
- preparing effective questionnaires and managing the interview process
- sourcing appropriate PIL testing volunteers
- reviewing product portfolios for PIL bridging strategies to reduce overall testing costs
- full user testing report, ready for submission to the relevant authorities.
Once your dossier is ready to submit we create the eCTD for you and manage the electronic submission using our in-house software.
We can create full eCTDs for new applications as well as convert dossiers in part or whole for older MA applications and variations. We also have extensive experience in Post Marketing Maintenance, maintaining your product by conducting licence transfers, variations, renewal applications, reclassification of medicines and Periodic Safety Update Reports (PSURs) to ensure that your product continues to meet the necessary standards of safety, efficacy and quality.