Catherine Bernard, Ph.D.

Senior Regulatory Affairs Consultant

Dr. Bernard directs our regulatory efforts and is a key strategist working closely with our client’s submission team. At DSI, Catherine oversees the regulatory aspects of API synthesis, delivery of clinical trial materials (CTM) (formulation, manufacturing, analytical testing, packaging, stability) and the coordination of chemistry, manufacturing and controls (CMC) information into regulatory filings. She has more than 25 years of experience in the pharmaceutical industry, with an extensive background in defining regulatory strategies to achieve corporate goals and moving early stage drug development programs to global regulatory submission and commercial launch.

Dr. Bernard is a subject matter expert for submission life cycle management including both large and small molecule in all dose formulations.

Before joining DSI, Catherine held the position of vice president of research and process development at VALORUM. She holds a Ph.D. in Biochemistry and Cell Biology from Université Paul Sabatier Toulouse III. She leads the CRO’s FDA and EMEA filing strategies in the UK. On behalf of our clients, she has successfully negotiated with agencies, submitting briefing books and in-person meeting attendance. Catherine is well versed in the many aspects of authoring in the electronic CTD format. In her time in industry, Catherine has supported multiple dosage forms at various stages of development.


Core Competencies

  • Author US, EU and ROW
  • Vaccines and Biologics
  • Combo Devices
  • Small Molecule
  • Briefing Books
  • Orphan Designated Products
  • FDA Modules 1,2,3,4,& 5
  • Clinical Protocols
  • 505(b)(2) Pathway