TMC has extensive experience of global regulatory affairs and submissions, offering strategic advice and expert guidance from pre-approval through to post-approval phases.

We’ve built a trusted team of global experts offering word-class support. These experts work with and produce submissions to all major authorities worldwide, including, but not limited to, North and South America, the UK, Europe – both centrally via EMA and individual competent authorities – AsiaPac and major African countries.

Our comprehensive portfolio of regulatory services includes:

Pre–Approval, Marketing Authorisation Approval (MAA) & New Drug Approval (NDA)

Post-Approval Regulatory Activities

Ensuring Compliance with the European Clinical Trial Regulation: Time is running out!

The European Medicines Agency’s (EMA) Clinical Trial Regulation (CTR) #536-2014 transition from the Clinical Trial Directive (CTD) 2001/20/EC has been a hot topic in the pharmaceutical industry for several years. As the January 2025 deadline is fast approaching, it is crucial for companies involved in clinical trials to take immediate action to ensure compliance, as failing to adapt to the new regulations could have severe consequences for ongoing trials and future drug development plans.

The European Commission (EC) and Member States (MSs) are strongly advising that the transition submission takes place before the 16th October 2024, to take advantage of the expedited procedure agreed by the Clinical Trials Coordination Group (CTCG), ensuring that the legislation is met within the timeline.

Adapting to the new regulations requires meticulous planning, coordination and regulatory expertise. Our customers can be assured of our experience and knowledge in navigating the CTR transition.

If you’d like to know more about how we can support the smooth transition, minimising any disruptions to ongoing trials and ensuring compliance with the CTR, please contact our team of regulatory experts today.

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Our team is ready and willing to support your regulatory needs.

To discuss your specific project requirements, contact us today.