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 submission and approval of its client’s product in Scotland.
Acting as their client’s UK Marketing Authorisation Holder (MAH), this milestone marks the first delivery of the rare disease product in the region.
Catherine Moncad, Vice President of Regulatory Services at TMC, commented: ‘It’s an honour to partner with clients who are investing in life-changing treatments for rare diseases. TMC is uniquely positioned to support organisations that lack an appropriate entity to hold licences in the UK and EU. Even for clients who can hold a licence, our team will provide comprehensive support to manage the life-cycle maintenance and post-approval submissions, ensuring smooth project delivery at every stage.’
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’s (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.