Catherine McHugh

Catherine McHugh

Catherine McHugh

Senior Director

As a Senior Director for Parexel, Catherine advises and consults with clients on all aspects of CMC drug development and regulatory affairs, on interactions with regulatory authorities, throughout the product development process, and written representations and appeals to the European and national regulatory agencies. She also prepares CMC drug development strategies for markets in Europe, the US, and the rest of the world; Quality Overall Summaries and other critical summaries for all global markets; and submissions for (s)NDA and MAA and variations for FDA, EMA and national regulatory authorities.

Work Experience

Catherine joined Parexel in 2014 after eight years as an Executive Pharmaceutical Assessor at the Health Products Regulatory Authority (HPRA); formerly the Irish Medicines Board (IMB). During this time she was the Irish ‘Human Medicines’ delegate to the joint CHMP/CVMP Quality Working Party at the European Medicines Agency (EMA) and rapporteur for the update to the EMA Guideline on Process Validation. Catherine has extensive experience of assessing the CMC section of dossiers for chemical products submitted to the IMB and EMA specializing in inhalation products. She has experience in the assessment of drug product and drug substance sections of MAA dossiers (including ASMFs), IMPDs, drug device combination products and labelling and product information. Prior to joining the IMB she was employed as a senior scientist in product development at 3M Healthcare in Loughborough, UK involved in the development of solution and suspension metered dose inhalers. She has also practiced as a Pharmacist in both the UK and Ireland.


Catherine has a degree in Pharmacy (B.Sc. Pharm) from Aston University and a Ph.D. (Pharmaceutics) from the School of Pharmacy, University of London. She is a member of the Irish Pharmaceutical Society and the Royal Pharmaceutical Society of Great Britain.

We are always available for a conversation.