We offer regulatory advising throughout the drug development and approval process, specializing in clinical trial design, safety planning and regulatory strategy.
Services
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Development Strategy
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Clinical hold/safety issues (IND)
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Clinical Trial Design
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Efficacy demonstration
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Safety Design
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Endpoints
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Feel/Function/Survive paradigm
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Patient Reported Outcomes/Clinical Outcome Assessment
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Market Viability/Investment Forecast
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Pharmacovigilance plans/reports
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Safety Signal investigation/reporting
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Clinical Trial findings
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Case Report Analysis
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Labeling
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Sentinel System
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Postmarketing required studies (PMRs)
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Risk Evaluation and Mitigation Strategies
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Market placement/Therapeutic landscape
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Regulatory precedent
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Accelerated approval
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Approach to Substantial Evidence of Efficacy
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NDA preparation/partnering
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DMC support
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FDA guidance/policy/navigation
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Surrogate endpoints
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Citizen Petitions
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Patient Advocacy
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.
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.
