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