Consultant Information

Both of our chief consultants, Charles Shen and Ray Wang, are seasoned scientists and regulatory affairs executives with over 15 years’ experience in the medical business, specializes in Good Manufacturing Practices auditing, consulting, and training. They have made numerous successful 510(k) submissions or ANDA applications, and have assisted from small to large manufacturers to become GMP compliant and pass FDA inspections. Before becoming independent consultants, they have directed R&D, regulatory affairs, and quality assurance efforts in companies such as Boston Scientific, Teva and Merck.

Both of our chief consultants received their Ph.D degrees in chemistry or biomedical engineering.

Domestic and International FDA Consulting