Assessments

Our Assessment services can help you assess yourself against regulatory (GMP and CMC), compliance, best-practice and quality maturity expectations.

• GMP Assessments: Where does your company stand in terms of regulatory expectations (e.g. inspection readiness, observations, compliance status, regulatory actions)? How does this compare with other companies? Do you have an upcoming inspection?   
• Inspection Readiness (PAI, Surveillance or For-Cause): We can help you with inspection readiness (e.g., by conducting mock inspections led by ex-FDA site inspectors). 
• Responses: Have you recently received an FDA 483 list of observations or a warning letter from a regulatory agency? We can help you with your response by conducting mock review led by ex-FDA compliance reviewers. Have you had to recall batches? 
• Batch Review & Certification: Have you had site inspection observations regarding batch record review or investigations? We can help you with batch review and certification.
• CMC Readiness: Do you have an upcoming new product filing and change submission? 
• New Products: We can help assess your readiness for regulatory filing
• Changes: We can help assess your readiness for change filings
• Quality Management Maturity Assessments: We can assess you against best-practice and quality management maturity expectations.
• Supplier Assessments: We can assess your suppliers and the supply chain against regulatory, best-practice and quality management maturity expectations.