Welcome to

TMC Pharma

Your complete end-to-end partner for pharmaceutical development

TMC is a unique drug development organisation, offering a full range of support services to the Pharma and Biotech industries. We know that no two drug development programs are the same, and we therefore believe that, to maximise success, each client should receive a bespoke approach to their particular drug development requirements and challenges.

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TMC Pharma is proud to partner with Genetic Alliance UK and ITN Productions to help raise awareness around the challenges faced by individuals suffering from Orphan Disease, but also the complexities in bringing effective therapeutics to market. Watch to find out more about how TMC helps overcome these challenges.
Orphan Drug specialisation
Orphan disease is defined as a condition that affects fewer than 5 in 10,000 people. This exceptionally low incidence creates significant challenge in the design and execution of clinical trials for new therapeutics.

Here at TMC, we understand those challenges intimately, and our dedicated team of specialists and global Associates are ready to offer that expertise. Our team passionately believe that those affected by Orphan Disease should not feel marginalised in society by their conditions and our team is dedicated in bringing therapies to market that will allow those affected to live as normally as possible.

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What our clients say
“You were recommended to us by one of our CRA’s colleague. She said you were one of the best CROs she has ever worked with and that you take care of your CRAs and show your appreciation of them. That to me is one of the best notes of praise I have ever seen!”
Head of Clinical Operations, US Biotech Client
“Thanks to all of you for being champions. Thanks to those who did the running and heavy lifting and to those who were cheering everyone else on. As an additional benefit, we got to know each other well through countless conference calls and meetings. I found that the most rewarding aspect of our collaboration.”
Chief Medical Officer, Global Pharma Client
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What We Do
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 900 personnel (Employees and Associates) includes some of the very best subject-matter experts in medicinal product development.

Each project team is hand-picked to match the needs of a client. The team 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 the 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 engaging with new Associates as required in order to provide expert current, local knowledge.

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 company 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) Limited

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

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Orphan / Niche Products

Pre-Approval
Post-Approval

Achi

Vice President Clinical

Victoria joined TMC Pharma in 2022, bringing with her over 20 years of clinical development experience within global clinical research, including both project management and line management.

A medically qualified doctor, her extensive experience covers all clinical trial phases across a broad range of indications and therapies with particular expertise in oncology/cell therapy.

Victoria’s Clinical Services team comprises experienced and highly capable Project Directors, Project Managers, CRAs and CTAs allowing her direct oversight and governance of all aspects of our projects.

Dr Victoria Datsenko

Vice President Clinical

Victoria joined TMC Pharma in 2022, bringing with her over 20 years of clinical development experience within global clinical research, including both project management and line management.

A medically qualified doctor, her extensive experience covers all clinical trial phases across a broad range of indications and therapies with particular expertise in oncology/cell therapy.

Victoria’s Clinical Services team comprises experienced and highly capable Project Directors, Project Managers, CRAs and CTAs allowing her direct oversight and governance of all aspects of our projects.

Quentin Clarke

Head of Pharmacovigilance

Quentin has been working in the pharmaceutical industry for over 30 years, starting in Medical Information at Leo Pharma, where he moved into pharmacovigilance. Subsequently, he moved to run PV departments in service organizations such as MDS Pharma and Aptiv solutions. He has been an EU QPPV for multiple projects and more recently a UK QPPV.

Quentin has vast experience in both pre-and post- marketing PV surveillance and case management. His very broad experience of course encompasses managing PSMFs, EU and local RMP documents, periodic reports etc. as well as signal detection /review processes.

Quentin joined TMC in 2020

Andrew Green

Head of Finance

Andrew started his career in a variety of roles including a significant period as a Junior Partner in accounting practice.

In November 1998 Andrew joined Quintiles, then the largest CRO, and since has had a varied career working in most of the service lines, including Clinical Operations, Centralised Monitoring, Data Sciences, Safety and Regulatory where he gained Orphan Drug experience, and therapy areas including Oncology, Cardiovascular and CNS.

Andrew has supported annual revenues of up to $1bn and teams of up to 9000 staff across the world.

Andrew joined TMC in November 2021. He is a Fellow of the ACCA.

Catherine Moncad

Head, Regulatory Services

With a Joint Honours degree in Biochemistry and Biology, Catherine entered the pharmaceutical industry taking a Data Management role at PAREXEL before moving to Regulatory Affairs, via R&D, at Reckitt Benckiser.

Catherine has since held regulatory roles at Dr. Reddy’s, Smith & Nephew, Chiltern and PRA gaining experience in OTCs, generics, devices, prescription pharmaceuticals and wide clinical trial experience.

Acting as Global Director of Regulatory Affairs at PRA, Catherine managed a team of ~50 regulatory affairs staff across the UK, Russia, Ukraine, Georgia and Germany.

Catherine joined TMC in March 2017.

Marcelo Vaz, MD, PhD, FFCP

Head, Medical Services

Having qualified in 1992 and with an early career specialising in Pulmonary academia and clinical practice, he moved to the pharmaceutical industry in 2007, initially as a Senior Clinical Research Physician before becoming a Medical Director at a large CRO.

Marcelo developed clinical research expertise across the range of respiratory diseases, including COPD, Asthma, Lung Cancer, Cystic Fibrosis, Respiratory infections, Sepsis, mechanical ventilation, ARDS and SIRS.

Other areas of clinical research experience include CV, TGI, rheumatology, woman’s health, oncology, ENT, CNS, DM. His rare diseases expertise includes supporting strategic creation of drug development plans, protocol concepts, and from classic to adaptive study designs.

Marcelo joined TMC Pharma in 2022.

Carol Woodward

Chief Operating Officer

After completing her initial degree at the University of East Anglia, Carol joined the pharmaceutical industry, working at Lederle Laboratories, Schering AG before joining Shire Pharmaceuticals. In the latter she contributed to the drug development process as a Program Leader. During this time Carol also completed an MSc in Clinical Research at the University of Wales.

Carol has extensive experience across many therapeutic areas, particularly oncology, and all development phases and held roles in both Pharmaceutical and Clinical Research Organisations including senior positions such as the Global Therapeutic Head of Haematology/Oncology at PPD and Vice President Development Innovations and European Operations at Sarah Cannon.

Carol joined TMC in March 2020.

Julie Matthews

Chief Executive Officer

Trained in microbiology, Julie ran an academic hospital research laboratory in Cambridge (UK) prior to joining Warner Lambert Clinical Development Group in 1986, where she ultimately became International Therapy Area Director. She then joined Rhone Poulenc Rorer in France, where she was involved first in oncology clinical development, and subsequently as Head of Anti-infectives Clinical Development.

Julie then joined Orphan Europe in Paris as Head of Clinical Development and Regional Business Manager, before going on to set up and run the company’s UK affiliate, as General Manager responsible for drug and business development, regulatory affairs, sales and marketing.

Julie started TMC in the year 2000.