Dr Mike Cope is a GMP auditor, technical writing consultant, and founder of Cope Pharma Consultancy. He has over 30 years experience in the pharmaceutical industry, working primarily in Analytical Development and Quality Assurance.


Outsourcing and Regulatory:

Initiated, managed, and audited the outsourcing of stability and inhalation testing to CROs in Europe, the US and India in order to reduce costs, cut timelines and enhance data quality. Authored, reviewed and compiled key CMC documents for NDA and European regulatory submission.

Technical and Operational:

Led the design and installation of a new UK development laboratory for inhalation products. Set up infrastructure of laboratory, recruited staff and built successful and productive team of analytical scientists.

Management and Leadership:

Led and managed a team of graduate scientists engaged in the generation of analytical/CMC data and successfully achieved regulatory submission in the US for a number of inhalation products. Coordinated analytical development projects with colleagues based in Germany, the US and India to achieve rapid method transfer and product development.


Cope Pharma Consultancy, Woking, Surrey, UK.

GMP Auditor and Technical Writing Consultant, 2011 - present

Boehringer Ingelheim, Bracknell, Berks, UK.

Analytical Development Manager, Drug Delivery, 1996 - 2010
Chemistry Services Manager, Quality Assurance, 1994- 1996

Marion Merrell Dow, Winnersh, Berks, UK
Section Leader, Pharmaceutical Analysis, 1984–1994  


B.Sc (hons) Chemistry (Birmingham University)

Ph.D. Analytical Chemistry ‘HPLC of organophosphorus compounds’ (Birmingham University)

Postdoctoral Research Assistant - Inductively Coupled Plasmas (UMIST)

C.Chem. FRSC