compliance  +  regulatory  +  training
About Us

Catherine Bernard, Ph.D.

Dr. Catherine Bernard has over 10 years of industry experience, and since 1995 has worked in the regulatory affairs field. She started her career in Research in the US, and later moved to Europe to work as a regulatory affairs manager in two different CROs based in the UK. There she gained extensive experience in European registration (mutual recognition procedure and centralized procedure) for a wide variety of products and was involved with all the different parts of an EU dossier, from writing expert reports on the three main sections, clinical summary up to the assembly, submission and follow-up.

Since 1999, Dr. Bernard has consulted on FDA and European regulatory affairs, and has attended several pre-submission meetings with European Agencies as well as with the FDA. Projects have included preparation of technical reports and investigation reports, preparation of CMC sections for FDA submissions, preparation of CTDs, audits of data generated in research laboratories in support of an IND, and other regulatory documents. Dr. Bernard speaks fluent French.

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