TMC, a global clinical research organisation (CRO) dedicated to supporting the progression of life-saving drug development solutions for rare diseases, has announced its successful appointment as the UK Marketing Authorisation Holder (MAH) for one of its client’s seeking commercialisation of their product in the UK.
Catherine Moncad, Vice President of Regulatory Services at TMC, commented: ‘This is a significant achievement for our team, marking our first successful approval under the new International Regulatory Procedure (IRP Route A) introduced by the MHRA. It represents a key milestone and showcases our capability in navigating this innovative regulatory pathway.’
As part of its commitment to building a trusted partnership, is the company’s unique ability to act as their client’s MAH, spearheading the legal and regulatory accountability to ensure compliance with safety and efficacy standards, while supporting the commercial success of the product and gaining approval within the 60-day timeframe outlined by the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) guidance.
As a specialist CRO for rare disorders and diseases, TMC has extensive experience with all types of regulatory submissions in this area – particularly across the company’s key specialisms in oncology, neurology, respiratory, haemotology, ophthalmology, neonatology, hepatology and nephrology diseases.
Additionally, following the European Medicines Agency (EMA) significant regulatory submissions fee increases from January 1st 2025, TMC is proud to be an established EU/EEA-based MAH with SME representative status, meaning their client’s benefit greatly by securing substantial discounts on their fees.