Hugh Delargy Associates Ltd

About Us

Hugh Delargy Associates Limited is a pharmaceutical regulatory consultancy specializing in European CMC (Chemistry, Manufacturing and Control) subjects.
	Hugh Delargy is the Principal Consultant and his past experience as a UK licensing assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) and his current role as a Quality Assessor on the WHO Prequalification Programme enable him to provide valuable insight to his clients working on products for clinical trial approvals and marketing authorisations in the EU.

The business also draws on the services of Carolyn Delargy, a life-science graduate with 8 years’ experience in Regulatory Affairs at Aventis and, as needed, on various co-workers who for the most part have a background of working in a number of European regulatory authorities. Carolyn has a master’s degree in toxicology from the University of Surrey.

Hugh is also a registered pharmacist, international lecturer and scientific author. He worked as a senior assessor at the MHRA for over 8 years. During his tenure of posts in both Licensing and Post-Licensing divisions he assessed approximately 90 new chemical entities and abridged applications and numerous variation applications.

Hugh was a senior associate director in regulatory affairs with Pfizer Global Research and Development for four years with significant responsibility for several “blockbuster” products.

Earlier Hugh was a senior manager in pharmaceutical R&D for a division of Bristol-Myers Squibb with a focus on development of analytical methods, stability testing and formulation innovation.