Assessments
Assess yourself against regulatory (GMP and CMC), compliance, best-practice and quality maturity expectations.
Schedule a ConsultationOur Assessment Services
Comprehensive evaluations led by industry experts and former FDA inspectors
GMP Assessments
Where does your company stand in terms of regulatory expectations including inspection readiness, observations, compliance status, and regulatory actions?
Key Features
- Inspection readiness evaluation
- Observation analysis
- Compliance status review
- Regulatory action assessment
Benefits
- Clear compliance picture
- Risk identification
- Improvement priorities
- Regulatory confidence
Mock FDA Inspections
Mock inspections conducted by former FDA inspectors for PAI, surveillance, and for-cause inspections.
Key Features
- PAI mock inspections
- Surveillance mock inspections
- For-cause inspection simulation
- Former FDA inspector led
Benefits
- Inspection confidence
- Risk identification
- Team preparation
- Reduced observations
FDA 483 & Warning Letter Response
Assistance with FDA 483 observations and warning letters through mock reviews led by ex-FDA compliance reviewers, plus batch recall support.
Key Features
- FDA 483 response support
- Warning letter assistance
- Ex-FDA reviewer guidance
- Batch recall support
Benefits
- Expert response
- Compliance restoration
- Regulatory relationship
- Risk mitigation
Supplier Assessments
Assess your suppliers and the supply chain against regulatory, best-practice and quality management maturity expectations.
Key Features
- Supplier evaluation
- Supply chain assessment
- Best-practice benchmarking
- Maturity evaluation
Benefits
- Supply chain confidence
- Risk reduction
- Quality assurance
- Vendor management
Ready for an Assessment?
Let's evaluate your quality systems and identify opportunities for improvement.