International Regulatory Affairs Services, Inc.
10626 Wagon Box WayHighlands Ranch, CO 80130
USA
Tel: (1) 720.939.9952
Fax: (1) 303.683.3512
Email: cbernard@iras-regs.com
President: Catherine Bernard, Ph.D.
Dr. Catherine Bernard is the President and Principal Consultant of International Regulatory Affairs Services, Inc. Dr. Catherine Bernard has over fifteen 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, Canada, Europe and Latin America.
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 and was involved with all the different parts of an EU dossier including writing expert reports. In 1999, Dr. Bernard moved to the US and has been consulting on FDA, European, Canadian and Latin American regulatory affairs since then. Over the past five years Dr. Bernard has broadened her experience with Regulatory Compliance and has helped Companies to develop and maintain good compliance status through review of quality systems effectiveness, audits and remediation programs. Dr. Bernard speaks English and French.
Biographies of our other consultants will be provided on request.
