Judy joined NDA in 2020 as a Principal Consultant working with small and large cap companies across multiple therapeutic areas. She serves as a US Agent for clients leading the submission of their INDs, NDAs, and special designation requests (i.e. Orphan Drug Designations).
Key Areas Of Expertise
- IND, NDAs (505)(b)(1) and 505(b)(2), BLA, IDE and PMA dossier submissions
- Health Agency Meetings including pre-IND, End-of-Phase 1 and 2, pre-registration and Scientific Advice
- New product development programs including expediated review pathways (i.e. FDA accelerated approvals, breakthrough designation, fast track and rolling review submissions)
- Novel registration strategies including use of the 505(b)(2) regulatory pathway to register new dosage forms, expanded uses/indications including four Rx to OTC switches.
- FDA Advisory Committees (preparation and presenter)
- Due Diligence for mergers and acquisitions
- US Agent for ex-US companies
- Drug-Device combination products and regulatory strategies
- Post marketing requirements including Pediatric Research Equity Act (PREA)
Judy spent over 25 years in the Biopharma Industry, primarily working in the discipline of regulatory affairs. She held positions of increasing responsibilities and last served as a Vice President of Global Regulatory Affairs. Judy has served as the regulatory lead for therapeutic drug products, both small and large molecules, and devices. She has worked across multiple therapeutic categories that included respiratory, allergy, rheumatology, metabolic/endocrine (including women’s and men’s health), dermatology, oncology, CNS, and gastrointestinal compounds.
Judy is a recognized expert in nonprescription drug products and has completed 4 Rx-to-OTC switches. Her experience includes registration submissions and multiple approvals, FDA Advisory Presentations and serving on FDA/Industry working panels.