Who is IRAS, Inc.
International Regulatory Affairs Services, Inc. is a consulting group dedicated to the Pharmaceutical Industry. IRAS, Inc. focuses on addressing product development challenges. Our subject matter experts (SMEs) provide specialized services on a wide range of topics, ranging from individual technical solutions, to building frameworks for organizational design and decision making, to regulatory affairs and quality assurance to expedite product development, registration and commercialization.
Dr. Catherine Bernard
Dr. Catherine Bernard is the President of IRAS Inc with over twenty years of industry experience. She started her career as a scientist in R&D and since 1995, she has worked in the Regulatory Affairs field assisting companies in developing their regulatory strategy and helping them establish a relationship with regulatory agencies in the US, Canada, and Europe. In 1999, Dr. Bernard moved to the US and continued consulting on FDA, European, and Canadian regulatory affairs. 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.
The benefits of working with our team:
• We are a small group of consultants led by Dr. Catherine Bernard who have worked together before on a variety of projects
• We consider ourselves as an extension of your company
• We are hands-on consultants
Our Services • REGULATORY AFFAIRS • REGULATORY COMPLIANCE • ELECTRONIC PUBLISHING • US AGENT • VALIDATION
