Founders

Catherine Bernard, Ph.D

Dr. Catherine Bernard  has a Ph.D. in cell biology and biochemistry, and over 20 years of industry experience.  Since 1995, she has worked in the Regulatory Affairs field assisting companies develop their regulatory strategy and helping them establish a relationship with regulatory agencies in the US and Europe.  She started her career in Research in pharmaceutical companies and later worked as a regulatory affairs manager in two different CROs based in the UK. There she gained extensive experience in European registration for a wide variety of products.  In 1999, Dr. Bernard moved to the US and has been consulting on FDA, European regulatory affairs since then.  Over the past five years Dr. Bernard has broadened her experience with Regulatory Compliance and have helped Companies to develop and maintain good compliance status through review of quality systems effectiveness, audits and remediation programs. Dr. Bernard speaks both English and French.