The breadth of the pharma/biotech development support services we offer; involving human & veterinary medicines & devices. The way we provide those services.
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:
We have pioneered the early development pathway for novel advanced therapy agents; right from the manufacturing stage.
A core team of highly-experienced senior executives in TMC's UK office collaborates with our loyal and established network of Associates which are located around the world. The TMC network includes some of the very best subject-matter experts in medicinal product development.
Our 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.
TMC works right across the size spectrum of pharma/biotech companies worldwide (from start-ups to Big Pharma) and Academic Institutions.
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:
We have extensive experience of successful submissions to authorities worldwide; covering all aspects and phases, both pre-approval and post marketing. Also, we probably have more experience with niche and orphan products than any other service provider.
TMC provides full pre-clinical support covering data review, liaising with non-clinical pharmacology and toxicology units, manufacturing/quality including import and release.
TMC provides full study strategic support and a truly comprehensive clinical trials service, from Phase I to IV. Along with more routine studies, we are highly experienced in running studies with products that have special requirements and also with orphan /niche products.
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.
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.
Our strategic and expert consultancy briefs have been many and varied, from relatively simple to highly complex, advising at all stages of development. We find it difficult to turn down any challenge. We also cover due diligence, QA audits, convening and facilitating KOL groups, Project Management.
Our Pharmacovigilance and Medical Departments work in close cooperation. They support clinical trials worldwide and can also cover all safety and medical requirements for products post-approval. TMC has its own fully compliant safety database if required.
TMC’s experienced industry physicians support all aspects of the sponsor’s medical function from clinical trials through post-approval responsibilities. We have 24 hour medical cover and presence spanning all time zones if required.
Our medical writers include members of the American Medical Writers Association and founder members of the European Medical Writers Association. TMC writes and edits all types of documentation, whether for internal company use, regulatory submission, publication or marketing support.
TMC is supporting and encouraging non-Japanese companies to include Japan in their development programs from the outset. Conversely, TMC is also offering to support Japanese companies to develop their products outside of Japan.