Overview
Identifying a risk is only the first step. We provide actionable strategies to mitigate those risks, whether through additional studies, alternative regulatory pathways, or operational changes. We help you fix the problems we find.
Key Features
Remediation roadmaps
Alternative development scenarios
Agency engagement strategies
Contingency planning
Our Process
1
Prioritize
Ranking risks by severity and impact.
2
Solutioning
Developing specific fixes for each risk.
3
Implementation
Guiding the execution of the plan.
Project Complete & Deliverables Provided
Frequently Asked Questions
We use a risk matrix considering severity (impact on approval/safety) and likelihood (how certain is FDA to find it?). Critical risks that are certain to be caught get immediate attention. We also consider interdependencies—some fixes enable others. The result is a sequenced remediation roadmap that addresses the most important issues first while managing resource constraints.
Why Choose Us
- Path forward for troubled assets
- Cost-effective solutions
- Restored stakeholder confidence
- Saved programs
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Schedule ConsultationWhat Our Clients Say
"After a Complete Response Letter, we were stuck. Adelphi developed a mitigation strategy that reframed our efficacy argument, addressed the CMC concerns with targeted studies, and prepared us for a successful Type A meeting. We were approved 11 months later."
Dr. David Park
CEO
Biotech Company
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