Overview
Whether you are preparing for a submission or buying an asset, you need to know where the bodies are buried. Our gap analysis digs deep into the data, documentation, and strategy to identify compliance risks, missing data, and scientific weaknesses.
Key Features
Data integrity review
Compliance vs. Guideline assessment
Submission readiness check
Strategic alignment review
Our Process
1
Review
Systematic evaluation of the data room.
2
Identify
Flagging critical, major, and minor gaps.
3
Report
Delivering a detailed risk map.
Project Complete & Deliverables Provided
Frequently Asked Questions
A comprehensive gap analysis reviews all regulatory-relevant data: nonclinical studies (GLP compliance, study design), clinical trials (GCP compliance, protocol deviations, data integrity), CMC documentation (process validation, stability data, impurity profiles), regulatory submissions history, agency correspondence, and strategic alignment with current guidance. We look for missing data, outdated studies, and compliance issues.
Why Choose Us
- Clear view of program risk
- Prioritized remediation plan
- Accurate valuation
- Negotiation leverage
Get More Details
Request a personalized consultation and detailed information about this service.
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Schedule ConsultationWhat Our Clients Say
"We thought we were 6 months from filing our NDA. Adelphi's gap analysis revealed critical stability data gaps and a process validation issue that would have resulted in a CRL. We fixed them before filing and received approval on the first cycle."
Dr. William Foster
VP Regulatory Affairs
Biotech Startup
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