OK This website uses cookies to ensure you get the best experience on our website More info TMC Pharma Services × COVID-19 (Coronavirus) Notice In light of the current global Coronavirus-related situation, we want to reassure you that TMC is working hard to ensure all controllable aspects of our services continue as normally as possible, and that any disruptions caused by restrictions in travel etc. are minimised as much as possible. Supporting our ongoing projects is obviously key and we will continue to manage and monitor our projects and liaise with you as needed. At TMC, we are of course monitoring daily the available global and local advice on precautions necessary to curtail the spread of Covid-19, and we are taking appropriate measures to manage the continually-changing situation. We have a robust Business Continuity Plan (BCP), which allows all of our team to work remotely should the need arise. We have recently reviewed our BCP in the light of this extraordinary situation to ensure all business critical functions will continue if our employees have to self-isolate. A Unique Global Pharmaceutical Development Organisation Providing a Full Range of Expert Pharma/Biotech Support Services TMC is unique in two ways: Firstly The breadth of our services... We offer end-to-end services, from pre-clinical to post-marketing, Pharma/Biotech development services for human & veterinary medicines and devices. Secondly The way we provide those services... We tailor our range of services to every Client’s individual needs and our worldwide team of over 800 mature experts can be used to manage as much, or as little, as a client company needs. What We Do TMC Pharma Capabilities [ PDF ] Our development support activities span early pre-clinical phase right through to post-marketing. TMC provides all the functions of a fully-resourced pharmaceutical company and we often provide 'bolt-on' services complementing a client's in-house resource to enable them to have all the development capability appropriate to the stage of their project. We cover all therapeutic areas but have particular expertise in: Rare and orphan diseases Advanced Therapy Investigational Medicinal Products including stem cells and other cell-based therapies Oncology including biologics and immuno-oncology We have pioneered the early development pathway for novel advanced therapy agents; right from the manufacturing stage. How We Do It The TMC network of over 800 personnel (Employees and Associates) includes some of the very best subject-matter experts in medicinal product development. Our specific teams are hand-picked to match exactly the needs of each individual project, they evolve smoothly along with the progress of the project, responding intelligently to the specific needs at each stage of development, driving the project to a successful conclusion. This approach makes us nimble, light on our feet, flexible and cost-effective. Where We Do It TMC is working all over the Globe. We have offices and hubs in key countries – particularly in EU, USA, UK and Japan. Our core team of highly-experienced Senior Executives in TMC's Head Office collaborate with our loyal and established network of Associates located around the world. We are continuously adding Associates to the team, as required, and they all provide expert, current, local knowledge. Our Clients TMC works right across the size spectrum of pharma/biotech companies worldwide (from start-ups to Big Pharma) and Academic Institutions. Partnership: The TMC Way Of Working TMC came from a consultancy background. This makes us different from other service providers: we prefer to act as partners with our clients, providing a blend of consultancy/strategic advice and efficient implementation. Our highly experienced team has an outstanding track record of delivering successful projects across the following disciplines: Regulatory Affairs We have extensive experience of successful submissions to authorities worldwide; covering all aspects and phases, both pre-approval and post marketing. Market leader in niche, ATMP & Orphan Products. Pre-Clinical Development TMC provides full pre-clinical support covering data review, liaising with non-clinical pharmacology and toxicology units, manufacturing/quality including import and release. Clinical Development & Operations Product Development Strategy & Planning, full-service support for Phases I-IV clinical trials. TMC is a Market leader for rare populations & Orphan Products. Post Approval / Marketing TMC holds Marketing Authorisations in Europe and other ex-US territories (providing regulatory maintenance, medical and scientific service, distribution, etc) on behalf of clients when required. Orphan / Niche products The TMC team probably has more Orphan Product and cell therapy experience than any other service provider. We obtain and hold Orphan designations worldwide, run clinical trials quickly, and support pre- and post-approval marketing. Consultancy / Strategic Advice Strategic, expert consultancy, across all stages of Pharma/Biotech/Device development Global Dev. Plans, KOL management, Project Management, Audits & Pre-Approval Inspections. Pharmacovigilance Global pre- & post-approval safety management, (cases, periodic reports, PSMFs), experienced QPPVs, expert medical support, using an Argus database. Medical Experienced Industry Physicians that support Sponsor’s PV & Medical teams. Extensive clinical trial experience, pre- & post-approval, 24-hour global Medical cover. Medical Writing TMC’s team Include members of AMWA & EMWA, experts in all documents, e.g. study docs, regulatory submissions, publications, marketing materials. Japan Local Japan presence, facilitating early inclusion of Japan into Global Development Plans, support Japanese companies to develop their products globally. TMC Pharma (EU) Ltd TMC’s Irish office provides all the services that require a presence in the EU for both pre- and post-marketing. TMC North America Local North America presence (Maryland), support North American activities, Regulatory, Clinical Ops, PV, Medical. TMC Pharma Services Ltd Lodge Farm Barn Elvetham Park Estate, Fleet Road Hartley Wintney, Hampshire RG27 8AS United Kingdom Contact Us +44 1252 842255 info@tmcpharma.com Registered in the UK, No. 4241825 Privacy Policy © TMC Pharma 2021 Website by ASAP