Meeting regulatory and compliance expectations
Auditing
CQMP offers specialized auditing service of vendors, suppliers and contract laboratories. We can assist you in building a vendor qualification program for raw materials or services.
Risk Assessments
CQMP also provides internal auditing services and can provide a report based on quantitative evaluations of programs, procedures, policies, and practices at your site(s). Relative risk of each parameter or area reviewed will provide prioritization awareness needed to successfully remediate any situations not in compliance with agency, industry, or internal standards.
Regulatory Consulting
CQMP helps clients develop and implement sound cGMP compliance strategies. CQMP can assist your company with these and other compliance an regulatory activities.
- Preparation for FDA inspections, particularly pre- and post-approval inspections
- Evaluation of Quality Systems with quantitative evaluation reports
- QA / QC documentation review
- Development of Quality Systems
- Plan Presentations to FDA
- Development of Quality System SOPs
- Design Reviews
- Responses to FDA observations or action