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UK Sales

Jeremy Pitt

Commercial Director UK, Ireland & Nordics

Abdullah Yassin

Business Development Manager

Key members of our team

Audrey Toulemonde

Associate Director, Medical Devices/IVD
Audrey has over ten years experience in all aspects of regulatory affairs for medical devices or drug-device combinations in EU and the UK, from product development and clinical investigation to creation of technical documentation and lifecycle management. She has extensive experience in literature searching and clinical evaluation writing for various medical device technologies. She is knowledgeable in medicinal products regulatory requirements with experience in clinical trials applications, marketing authorization applications and life-cycle maintenance.

Ros Henley

Senior Director, Healthcare Compliance & Medical Review

Ros has both a scientific and legal background and has worked in healthcare compliance (HC) for over 20 years. She leads our HC and medical approval teams. Ros has worked in several US and Japanese companies and also spent a number of years on the Panel at the Prescription Medicines Code of Practice Authority (PMCPA). Ros has been a consultant for over 10 years and specialises in “crisis management”, supporting clients to navigate activities such as complaints, appeals and PMCPA audits. Ros is the only HC consultant in the UK to support a company through the complaints process from the Code of Practice Panel level, Appeal Board and up to the ABPI Board, with a successful outcome.

Marla Smith

Senior Manager, Development Consulting & Scientific Affairs
Marla is a senior client relationship manager with over 15 years’ experience in nurturing new clients and expanding existing clients.
She is client orientated with a proven ability to manage both small and large projects from initial discussions through to completion whilst also keeping the wider operational team at the forefront of all decisions. Marla has extensive project management skills, anticipating and accommodating client workload to ensure projects are continuously and appropriately resourced.

Dora Amene

Associate Director, Pharmacovigilance

Dora is a Pharmacovigilance Associate Director at PharmaLex with 12 years of industry experience, working for both pharmaceutical companies and service providers. She holds an MSc in Pharmacovigilance and is a committee member for the Pharmaceutical Information and Pharmacovigilance Association (PIPA), where she serves as journal editor and PV compliance lead. Dora is helping lead our UK/Ireland PV team in the implementation of the day-to-day operational PV tasks for clients through our high-level consulting services.

Rob Worsley

Associate Director, Regulatory Affairs

Rob is an Associate Director in our Regulatory Affairs team with over 13 years' industry experience, including a wide array of experience and knowledge in both regulatory project work and technical areas specific to the Pharmaceutical Industry, with a primary focus on global CMC projects.

Andrew Harbrow

Associate Director, Promotional Materials & Compliance

Andy is a New Zealand trained and UK registered pharmacist and has fulfilled numerous senior management roles in medical affairs, medical information, medical compliance and project / programme management during his 25+ years in the pharmaceutical sector. Andy has split this time working for big global pharma companies and more recently, pharma service providers where he has established and developed global medical information teams and services. Andy is a UK Medical Signatory and manages the healthcare compliance and UK medical approval teams.

David Wilkinson

Director, Head of PER UK and Ireland

David is Head of Pharmacovigilance, Epidemiology and Risk Management with over 35 years of experience in the pharma industry and 25 years working within the pharmacovigilance (PV) sector. David has managed a variety of different PV projects and demonstrates the flexibility required to ensure that our clients can be assured of an efficient and compliant PV system to service their pharmaceutical products. He oversees a team of highly competent PV professionals who can maintain and operate all aspects of an end-to-end PV system and ensure the most appropriate level of support, dependent on each client’s specific needs.

Regina Dawkins

Director, Practice Area Lead QMC
Regina has 30 years experience in the pharma industry, relating to API’s, Manufacturing, Storage, Distribution and Transportation.
She leads our Commercialization Readiness service and provides Quality Management & Compliance support in areas such as Manufacturing Importation Applications (MIA), Qualified Person (QP), Responsible Person (RP/RPi), Wholesale Distribution Application (WDA), Exploitant services, GMP/GDP compliance evaluations and risk assessments, Product launches and new market entry (including global supply chain), and Narcotics licensing. Regina has acted as RP on Wholesale Dealers Authorisations (UK and Ire) and is expert in EU and US GMP and Controlled Substance regulations.

Graham Donaldson

Director, Regulatory Affairs

Graham is a Director, Regulatory Affairs at PharmaLex UK. Graham has over 19 years experience in pharmaceutical regulatory consultancy. Graham leads PharmaLex’s UK and Ireland Regulatory Centre of Excellence service delivery area. He advises a wide range of companies about their regulatory activities in the UK and Ireland.

Martin Mewies

Director CMC
Martin has 25 years of experience in protein biochemistry, with 20 years in biologics CMC / Regulatory, including new product development, MAA submissions, life-cycle management, capital projects and project management. His broad biological product experience includes recombinant proteins, vaccines, monoclonal antibodies, biosimilars and low -volume/high-potency molecules.

Tring

First Floor, St Peter’s House, Market Place, Tring, Hertfordshire HP23 5AE, United Kingdom

Redruth

Pool Innovation Centre, Trevenson Road, Pool, Redruth TR15 3PL, United Kingdom

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