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.
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.
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.
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.
Market leader in niche, ATMP & Orphan Products.
TMC provides full pre-clinical support covering data review, liaising with non-clinical pharmacology and toxicology units, manufacturing/quality including import and release.
Product Development Strategy & Planning, full-service support for Phases I-IV clinical trials.
TMC is a Market leader for rare populations & Orphan 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.
Strategic, expert consultancy, across all stages of Pharma/Biotech/Device development
Global Dev. Plans, KOL management, Project Management, Audits & Pre-Approval Inspections.
Global pre- & post-approval safety management, (cases, periodic reports, PSMFs), experienced QPPVs, expert medical support, using an Argus database.
Experienced Industry Physicians that support Sponsor’s PV & Medical teams. Extensive clinical trial experience, pre- & post-approval, 24-hour global Medical cover.
TMC’s team Include members of AMWA & EMWA, experts in all documents, e.g. study docs, regulatory submissions, publications, marketing materials.
Local Japan presence, facilitating early inclusion of Japan into Global Development Plans, support Japanese companies to develop their products globally.
TMC’s Irish office provides all the services that require a presence in the EU for both pre- and post-marketing.