Building Quality Systems Worldwide
About
Our consultants have diverse educational and professional backgrounds, with over 20 years experience in the medical device and pharmaceutical industries.
Our consultants have developed, implemented and maintained GCP compliant systems at leading manufacturers and research institutes. They have experience with GCP, GLP and GMP regulatory agency requirements, including US, EU, Japan, India, Canada, Australia, Brazil, and Argentina. They have succesfully led audit preparations and represented companies during FDA and Notified Body investigations.
Our consultants have extensive experience in Regulatory Affairs for both manufacturing and clinical. Their experience ranges from preparing regulatory submissions to meeting with regulatory agencies.
Whether you need to hire one of our experienced professionals by the hour, by the day, or on a project basis (short-term or long-term), our consulting experts can quickly provide you the answers and assistance you need.
