Specialty: Regulatory Affairs Consulting

Antony leads the electronic publishing of all eCTD format applications to the desired agencies, maintains the lifecycle of submissions, and corresponds with regulatory agency project managers. He manages and authors applications to the regulatory agency, including but not limited to: Orphan Drug Designation (ODD), Investigational New Drug (IND) application, FDA Type A/B/C Meetings, Rare Pediatric Disease (RPD) Designation, Breakthrough Therapy Designation (BTD), Fast Track Designation (FTD), Qualified Infectious Disease Products (QIDP) Designation, and others.

Antony also works with sponsors to develop regulatory strategy roadmaps and identify gaps in working submission packages.