The Investigational New Drug (IND) application is one of the most important applications in a drug’s life cycle, as it is a prerequisite for performing clinical trials in humans. The aim of an IND is to demonstrate every aspect of the drug (i.e., animal pharmacology, toxicology, manufacturing) is safe for human exposure. As a regulatory affairs consulting firm, BioPharma Global (BPG), a division of Pace® Life Sciences, offers a wide range of services for sponsors to help clients accomplish drug development goals, including IND preparation, authoring, and publishing.
Antony Kaprielian, Regulatory Operations Manager
With over 5 years regulatory experience, Antony manages the company’s in-house regulatory operations team, covering all regulatory submissions from early- to mid-phase FDA applications. He also publishes all eCTD submissions to ensure they meet both agency and company standards. Located in Virginia, Antony is also a jazz musician and nature photographer in his spare time.