Total submissions to FDA April – June 2023:  35 (on average almost 3 submissions a week!)

Early-stage development highlights: preparation/submission of 3 new INDs and submitted over 22 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, annual reports, safety reporting/DSURs); conducted formal meetings with CDER; prepared several gap analyses and regulatory development plans; ongoing review of public-facing information (e.g., websites, flyers, conference presentations) about investigational products; helped 1 organization find specialty investigational CDMO; and completed 1 CMC vendor qualification.

Late-stage development highlights: preparation of Phase 3 clinical regulatory strategies; developed several Phase 3 clinical trials; 1 late-stage gap analysis; supported 1 organization to secure external funding; supported 1 organization to divest product; helped 1 organization manage Phase 3/commercial CDMO; actively championed labeling negotiations for a new product pending approval; and ongoing ad promo strategy and document review.