Regulatory consulting for drug developers and sponsors, delivering FDA strategy to achieve accelerated approvals (Orphan Drug and Rare Pediatric designations, Fast Track, RMAT, Breakthrough) and to prepare IND/eCTD submissions. Provides tailored pre-contract data analysis, GAP assessments, INTERACT/Pre‑IND guidance, IND preparation and eCTD publishing with a track record of high success on orphan and pediatric designations.