Charles Heldebrant

Charles Heldebrant, Ph.D. has over 40 years of experience in biological and pharmaceutical product development, regulatory affairs, quality systems, process design, equipment and process validation, nucleic acid based diagnostics, analytical methods validation and computer validations.

Dr. Heldebrant is responsible for the entirety of PSC Biotech Corporation’s scientific and quality systems worldwide. He has performed numerous compliance, gap assessment and mock agency audits for foods, drugs, biologics, medical devices, botanicals and nutritional supplements throughout the world. He has conceived, developed and licensed biologic products; designed, executed and reviewed process validation studies and programs for biologic products and processes; prepared successful biologic license applications, new drug applications and investigational new drug applications; inspected, taught and validated aseptic filling of monoclonal antibodies and terminally sterilized emulsions; designed and operated stability studies and programs; and validated viral inactivation processes and medical devices; and provided quality assurance for contract manufacturing and software organizations. Dr. Heldebrant embodies the integrity and leadership of PSC.