We are hands-on problem-solvers who relish the fact that each project brings its own set of challenges. After assessing a client's needs, we assign a project-specific team with precisely the expertise needed to provide the best solution and follow it through to a successful conclusion.
Our support activities can start with product manufacturing and pre-clinical testing, then run through full product development to obtaining global Marketing Authorisations. Post-approval our support continues with regulatory maintenance, pharmacovigilance, scientific service and much more.
We work with the full spectrum of the pharma/biotech companies around the globe; from blue-chip multinationals to biotech start-ups. Our strength is working in partnership with clients. Our highly qualified team has an outstanding track record of delivering successful projects across the following main areas:
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.