Working with federal regulatory agencies on the specific issues affecting your business, we will ensure your activities comply with all of the regulations and laws pertaining to biopharmaceutical product development (GMP, Sarbanes-Oxley, OSHA, etc)


  • CMC/IND preparations and review
  • CMO on site and paper audits
  • FDA meeting attendee as product development representative for small organizations
  • Regulatory for veterinary products with US FDA CVM or USDA

Regulatory Team Specialist

Henry Hebel

Henry Hebel has over twenty years of experience in biologics development, production and regulatory compliance in major global markets.