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Craig Antony McCarthy

Craig McCarthy is highly skilled regulatory affairs consultant with International drug development experience and is a qualified UK Pharmacist (BSc, MRPharmS) with a post graduate business degree (MBA).

After completing his pharmacy degree and registration he spent a short time in hospital, military and community pharmacy before joining the pharmaceutical industry to develop his passion for regulatory affairs & drug development in which he has over 30 years’ experience in Cyanamid, CooperVision, Sterling Winthrop, Roche (as Head of UK Regulatory Affairs), PPD (as Director of Regulatory Affairs Europe, Asia & Africa) & Allergan (as Director, Regulatory Affairs, Europe, Africa & Middle East). In these senior regulatory positions in these companies, Craig has gained broad experience in regulatory leadership of numerous development programmes for new active substances in many therapeutic areas such as central nervous system, cardio-renal, gastrointestinal, ophthalmology, anti-inflammatory & analgesic, neuropharmacology, anti-infectives & anti-virals, oncology, endocrinology, dermatology, pulmonary, reproductive & urology and biologicals. He also has regulatory leadership experience in developing generic, medical devices, veterinary and OTC products. Craig in his various roles has also directed numerous meetings with International Regulatory Agency especially scientific advice and other face to face meetings with the EMA as well as project managing regulatory submissions and procedures for clients. He has extensive expert contacts in all areas drug development in the pharmaceutical. Biotech and healthcare Industries and the regulatory agencies in the EU.

In CAMPHARM, he has specialised in helping SME Companies to bring their products to EU quicker via innovative regulatory & development strategies and project manages these activities to achieve this aim, adding value to the Company profile.

Craig is passionate about the profession of regulatory affairs in drug development and has been on the Board of many leading International Regulatory Professional Organisations. He has been President and is also a Fellow of The Organisation for Professionals in Regulatory Affairs (FTOPRA). He has also been the President of the Pan European Federation of Regulatory Affairs Societies (PEFRAS). In these roles he has been involved with many senior representatives in International Regulatory Agencies, European Commission and other important International regulatory organisations & associations worldwide through chairing many International Regulatory meetings for these organisations. He also chairs the TOPRA annual Awards for Regulatory Excellence, an idea he had when he was President of TOPRA and has championed ever since. These awards honour those individuals or teams or Companies that have shown regulatory excellence in different unique categories.

He also has an MBA which links his passion for Regulatory Affairs & Product Development to the business and investment community. He is also a Fellow of the Chartered Management Institute (FCMI) and a member of Drug Information Association (DIA).
For his long military service, he was awarded a Territorial Decoration (TD)

Also look at his LinkedIn profile