The TMC Way Of Working

We originated from a consultancy background. This makes us different from most other clinical research organisations.

We work best when we work in partnership with our clients, providing a complementary blend of strategic expert advice coupled with efficient and comprehensive implementation of our services.

We have 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 for pre-approval and post-marketing activities. We are specialists in orphan, rare and oncology diseases and with innovative products, including Advanced Therapy Medicinal Products (ATMP), gene and cell therapies and devices.


We provide full pre-clinical support covering data review, liaising with non-clinical pharmacology or toxicology units and manufacturing/quality (including import and release).

Clinical Development & Operations

We offer clinical development strategy, planning and execution — providing full-service support for Phases I-IV of clinical trials.

Post-Approval Maintenance & Compliance Applications

We hold marketing authorisations in Europe and other ex-US territories (including providing regulatory maintenance, medical and scientific service, and distribution) on behalf of clients when required.

Orphan & Rare Disease Products

Our team probably has more product and cell therapy experience across orphan and rare diseases than any other service provider. We obtain and hold orphan drug designations (ODD) worldwide, run clinical trials quickly and efficiently, and support pre- and post-approval marketing.


Our team of experienced industry-leading physicians offer a complete range of medical services, providing support throughout the entire product development programme. We have extensive clinical pre- and post-approval trial experience; our expertise covers writing and editing all types of documentation for internal and external company use, as well as regulatory submission, publication and marketing support.

Quality Assurance

We can provide a comprehensive range of quality assurance services — from a one-off service to an ongoing extension of our clients’ quality management programmes.


Our pharmacovigilance and medical teams work closely together to provide a comprehensive suite of pre- and post-marketing services in this field.