Regulatory advising throughout drug development, approval, and marketing.
Drawing on decades of experience inside FDA.
PrincipalsNorman Stockbridge — Former Director, Division of Cardiology and Nephrology, FDA/CDER
Mary Ross Southworth — Former Deputy Director for Safety, Division of Cardiology and Nephrology, FDA/CDER
Mary Ross Southworth — Former Deputy Director for Safety, Division of Cardiology and Nephrology, FDA/CDER
Services
Development & trial design
- Development strategy
- Clinical trial design
- Efficacy demonstration
- Endpoints — Feel/Function/Survive paradigm
- Patient-reported outcomes / clinical outcome assessment
- Surrogate endpoints
- Approach to substantial evidence of efficacy
- Accelerated approval
- Data monitoring committee (DMC) support
- Clinical trial findings
Safety & pharmacovigilance
- Clinical hold and safety issues (IND and NDA)
- Safety planning for clinical trials
- Pharmacovigilance advising
- Safety signal investigation and reporting
- Case report analysis
- Sentinel System
- Risk Evaluation and Mitigation Strategies (REMS)
- Postmarketing required studies (PMRs)
Regulatory strategy & FDA navigation
- FDA guidance, policy and navigation
- Regulatory precedent
- NDA preparation and partnering
- Labeling
- FDA meeting strategy
- FDA meeting material review
Market & therapeutic landscape
- Market viability and investment forecast
- Market placement and therapeutic landscape
Meet the team
Principal
Norman Stockbridge
Dr. Stockbridge served in various capacities in the Division of Cardiology and Nephrology in FDA's Center for Drug Evaluation and Research and was Division Director from 2004 to 2025. He has a particular interest in innovative trial design and efficient use of evidence to support drug approvals.
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Principal
Mary Ross Southworth
Dr. Southworth brings over 20 years of FDA regulatory expertise in drug safety and pharmacovigilance, having served as the Deputy Director for Safety in the Division of Cardiology and Nephrology, Office of New Drugs in CDER. She has extensive experience with safety signal evaluation, drug labeling, clinical trial safety planning and evaluation, and risk mitigation/REMS.
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