Overview
Successful drug development requires more than good science—it requires disciplined program management that keeps all the moving pieces aligned toward your regulatory goals. Our program management services provide the strategic oversight and coordination needed to navigate complex development programs. We serve as your regulatory program manager, ensuring that CMC, clinical, and regulatory workstreams are synchronized, milestones are met, and nothing falls through the cracks.
Key Features
Our Process
Program Assessment
We evaluate your current development status, identify gaps, and establish a baseline for tracking progress.
Strategic Planning
We develop an integrated regulatory timeline with clear milestones, dependencies, and risk mitigation plans.
Execution & Coordination
We facilitate cross-functional alignment, track progress, and escalate issues before they become problems.
Milestone Achievement
We drive your program through each regulatory milestone, from Pre-IND to approval, with accountability and precision.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Single point of accountability for regulatory milestones
- Proactive identification and resolution of bottlenecks
- Optimized resource allocation across workstreams
- Clear visibility into program status and risks
- Experienced partner who has guided programs to approval
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Schedule ConsultationWhat Our Clients Say
"We brought Adelphi in when our program was struggling with coordination issues between our CRO, CMO, and internal teams. They established clear accountability, streamlined our meetings, and got us back on track for our NDA submission. Their program management was transformative."
Jennifer Williams
VP of Operations
Clinical-Stage Biotech
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