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

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

To discuss your specific project requirements, contact us today.