Overview
The culmination of years of development work comes down to your regulatory submission. Whether it's an IND to begin clinical trials or an NDA/BLA for marketing approval, every document must tell a compelling scientific story while meeting exacting FDA requirements. Our submission services provide end-to-end support, from strategy and planning through authoring, QC, and eCTD publishing. We've supported dozens of successful submissions and bring that experience to every project.
Key Features
Our Process
Submission Planning
We develop a detailed submission plan with timelines, assignments, and dependencies mapped to your target date.
Content Development
Our regulatory writers create submission-ready documents, working closely with your subject matter experts.
Quality Review
Multi-level QC ensures accuracy, consistency, and compliance with FDA formatting requirements.
Publishing & Filing
We compile the eCTD, validate against FDA specifications, and manage gateway transmission.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Proven track record of first-cycle approvals
- Experienced writers who know FDA expectations
- Integrated approach from strategy through submission
- Reduced internal burden on your team
- Confidence that nothing falls through the cracks
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Contact our team to discuss your specific needs for Regulatory Submissions.
Schedule ConsultationWhat Our Clients Say
"Adelphi managed our NDA from start to finish. Their writers produced outstanding Module 2 summaries, their QC caught issues we would have missed, and they published and submitted on time. We received approval without any major amendments."
Dr. Steven Richards
VP of Regulatory
Specialty Pharmaceutical
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Strategic oversight of Phase I-IV clinical trials, including protocol development and regulatory milestone management.
Program Management
End-to-end program management from IND through NDA/BLA, coordinating cross-functional teams.