Quality Affairs Services
Let us put our quality experience to work for you.
AAIPharma Services has an outstanding compliance history with worldwide regulatory inspection authorities. Staffed by experienced, senior level auditors and compliance professionals, the AAIPharma Services Quality team is primarily focused on assuring the quality of the services we offer our clients, and we also offer clients quality assistance across a wide range of areas in their own facilities.
The AAIPharma Services Quality staff has conducted audits throughout the US, Canada, Eastern and Western Europe, South America, Japan, India, China and South Africa. Quality team members come from a wide range of backgrounds including FDA, formulation development; analytical, microbiology and biotechnology laboratories; non-sterile and sterile clinical supplies and marketed product manufacturing, packaging and labeling and project management. AAIPharma Services Quality experts are experienced in:
- Sterile and non-sterile facilities
- CTM and marketed product manufacturing
- Controlled substances requirements
- GLP and GMP lab operations
As a contractor of services to the pharmaceutical industry, AAIPharma Services facilities, systems and practices are audited continually by our clients and regulatory authorities worldwide. Our strict adherence to the most rigorous pharma quality standards have resulted in an enviable history of successful GMP, GLP, and Pre-Approval Inspections.
