Overview
A company's history with regulators tells a story. We investigate the compliance history of potential partners or acquisition targets, reviewing 483s, Warning Letters, and correspondence to assess the culture of quality and regulatory standing.
Key Features
Inspection history analysis
Enforcement action review
Recall history assessment
Quality culture evaluation
Our Process
1
Search
Mining public and private databases.
2
Analyze
Looking for patterns of non-compliance.
3
Assess
Determining the impact on the deal.
Project Complete & Deliverables Provided
Frequently Asked Questions
We search multiple FDA databases: Warning Letters, Form 483 observations, import alerts, recall database, debarment list, clinical trial registry (for holds and terminations), and inspection classification database. We also check EMA and other global regulators for enforcement actions, and monitor court filings for consent decrees and qui tam actions. Our search is comprehensive and systematic.
Why Choose Us
- Identification of systemic issues
- Prediction of future compliance risk
- Character assessment of management
- Protection of reputation
Get More Details
Request a personalized consultation and detailed information about this service.
Personalized consultation
Detailed service information
Custom timeline & proposal
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for Compliance History Review.
Schedule ConsultationWhat Our Clients Say
"We were acquiring a company with 3 manufacturing sites. Adelphi's compliance review found one site had received 5 Form 483s with repeat observations on data integrity. We required the seller to remediate before closing and held back 15% of the purchase price pending FDA reinspection."
Laura Jackson
General Counsel
Pharmaceutical Acquirer
Related Services
Explore other ways we can support your regulatory needs