Founded PDCS in 1995, a consulting company that provides strategic and technical services to biotechnology, bio ***** and ***** companies in the area of outsourcing, technology transfer, regulatory, chemistry, manufacturing and control (CMC) projects. Worked with multiple investment firms conducting due diligence in the same areas to support investment decisions. He has 29 years of broad experience in product ***** of biological, bio ***** , ***** and botanical therapeutics. His working experience with the FDA includes CDER, CBER, CFSAN, and CDRH. This includes the preparation of multiple CMC sections, including CTD format, for regulatory filings (INDs, CTA, PMA, NDAs, BLAs, annual reports & International Dossiers). Attended multiple FDA meetings (pre-IND and post-IND) as the CMC liaison for clients and employers. He has consulted for over 30 different biotechnology, ***** , bio ***** and investment companies. Round Table Expert Witness Badge