Daniel B. Rego, Ph.D.
President, Regulatory Affairs and Quality Assurance
Daniel B. Rego, Ph.D., is a scientific consultant to the regulated industries, with over a quarter of a century of experience in the pharmaceutical and medical device industries. Areas of specialization include national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. He has regulatory expertise in constructing, testing, and validating quality systems and procedures. Areas of specialization include forensics, instrumentation, polymerization, handling of radioactive and irradiated materials, inorganic compounds and materials, and air/water sensitive syntheses, manipulations, and handling.
Daniel B. Rego, Ph.D. has constructed ISO and MRD (EU) compliant Quality Systems, including Quality System Manual and related Operating Procedures; constructed US FDA 510(k), EU (CE Mark), and other submissions to various international regulatory bodies; written scientific position papers and peer-reviewed academic papers.