Trac Services | Our Regulatory Experts | TRAC Services
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Our Regulatory Experts

The consultancy for global, pharmaceutical regulatory affairs

MEET OUR REGULATORY EXPERTS

Claire Pomeroy, Matthew Walker, Graham Donaldson, Sophie Brand and Lisa Pascoe are TRAC’s senior team, led by Jonathan Trethowan, one of TRAC’s co-founders.

Global yet individual

Their scientific and analytical expertise combines with TRAC’s comprehensive range of regulatory affairs services ensuring all aspects of your project are taken into account and managed, communicated and delivered effectively.

 

Comprehensive service

The lead consultants cover and specialise in therapeutic areas including analgesics, antibiotics, antidepressants, antihistamines, anti-infectives, anti-virals, cardiology, CVS, dermatology, GI, HIV, inflammatory, neurology, oncology, ophthalmology, respiratory, steroids, urology and vaccines.

Their experience and up-to-date knowledge of all things regulatory make them the expert choice for your resourcing needs: from CTAs, MAAs and Renewal submissions, and all types of Post-Marketing Applications, to the development of global regulatory strategies and all aspects of PIL testing.

 

Shaping the regulatory industry

All are active members of professional membership bodies such as TOPRA and hold a wide variety of positions: from committee and working party membership to SPIN group secretary and training course facilitator roles.

As well as their individual client, team and project responsibilities, they benefit from meeting regularly, exchanging ideas and learning from each other.

 

An eye to the future

Jonathan, Claire, Matthew, Graham, Sophie and Lisa take an active role training and mentoring their colleagues at TRAC and, what’s more, between them, they clock up over 350 lifelong learning hours a year!

Jonathan Trethowan

Jonathan Trethowan

Jonathan is co-founder of TRAC and oversees the regulatory team. He has over two decades’ experience in the industry as both a scientist and a regulatory affairs professional. Jonathan has built and shaped the team since TRAC took on its first employees in 2005, and with his guidance and support today’s senior team now trains and develops less experienced team members. A strong advocate for teamwork and networking, Jonathan’s drive for raising industry standards has recently seen him elected as President of TOPRA.
“I’ve had an interest in science and its application to health ever since I can remember and was attracted to regulatory affairs because it is at the forefront of ensuring that patients have access to the medicines they need. I get a real buzz from working with the great team we’ve assembled here at TRAC. As we continue to grow I’ve also been privileged to be able to further develop my remit through becoming more broadly involved in the industry through TOPRA and taking part in professional conferences and symposia.”
“Over the years, I’ve had a number of articles on User Testing and Pharmacovigilance published. My particular area of expertise is PIL design and presentation and I’m particularly proud of having developed TRAC’s User Testing service from scratch. With a 100% approval rate, my team tests whole product portfolios, creates strategies and rectifies any issues that arise.”
Sophie Brand

Sophie Brand

Sophie has been with TRAC for over ten years. With her background in pharmacovigilance and User Testing, Sophie is very patient focused and widely recognised for creating and managing effective processes and systems, as well as building excellent client, stakeholder and team relationships.
Graham Donaldson

Graham Donaldson

Graham brings exceptional clarity to the projects he leads. An outstanding communicator, he is known for being able to explain regulatory affairs to all sorts of audiences. As well as his work leading multi-faceted projects including managing a number of MAAs, he has been closely involved with TOPRA’s career guidance initiatives, contributing to the “Guide to Careers in Regulatory Affairs” and delivering training on TOPRA’s Spring Introductory Courses.
“With our experience of the increasingly complex and constantly evolving global pharmaceutical market* we believe that effective regulatory affairs consultancy sits at the very heart of making the most of your investment in the development, manufacture and marketing of your pharmaceutical products.”

*excluding North America

“I love the international aspect of my work, particularly managing and co-ordinating cross-border, cross-discipline teams. One of my most notable projects was a global drug product source transfer that involved client employees in Poland and the UK, as well as a three-strong TRAC team. All sorts of factors come into play with these projects, including language, culture, nuance, personality and processes.”
Claire Pomeroy

Claire Pomeroy

Claire has spent over a decade in regulatory affairs and specialises in CMC site rationalisation and compliance activities. Her strong strategic focus makes her ideally placed to head up key complex and international projects, working alongside clients’ senior regulatory management teams. Claire is adept at managing fast-moving, supply-critical work as well as being able to draw on the deep knowledge that client relationships going back five years have enabled her to develop.
Lisa Pascoe

Lisa Pascoe

Lisa’s experience covers the product lifecycle, from early development to post marketing support. Working with drug development companies she has provided clinical regulatory support which has involved IMPD and IB authoring as well as preparing and submitting CTAs. Lisa recently headed up a Value Engineering and Complexity Reduction project, co-ordinating a multinational’s in-house and external teams, developing and executing global variation strategies, project timelines and implementation plans.
“Being on-site, integrating with a client’s team as one of their own and managing delivery of a project from the client’s headquarters can, at times, be the best way of securing a successful outcome, particularly where time is of the essence. My leadership on a US-based project, which included six weeks on-site, has translated into a mutually valuable and on-going relationship with a major global client.”
“Collaborating and sharing best practice so that we’re continually improving regulatory industry standards is so important. I’ve been closely involved in devising TRAC’s own internal training programme and every year, as part of TOPRA’s CRED working party I help organise and deliver the Life Cycle Management: Variations training course.”
Matthew Walker

Matthew Walker

Matthew has led some of TRAC’s largest regulatory projects, including the renewal of 70 licences for lapsed or non-compliant registrations in West African markets for 33 individual products across 16 brands. His facility for engaging with a wide variety of stakeholders and translating strategy into actionable progress is a strength that he is committed to passing on to junior staff through his training and development role.
Take a look at our case studies for a more in-depth perspective on working with us