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Quality Affairs Services


Let us put our quality experience to work for you.

 

AAIPharma has an outstanding compliance history with worldwide regulatory inspection authorities. Staffed by experienced, senior level auditors and compliance professionals, the AAIPharma Quality team is primarily focused on assuring the quality of our client services, but also offers clients quality assistance across a wide range of areas.

 

AAIPharma Quality staff have 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, bioanalytical, microbiology and biotechnology laboratories; non-sterile and sterile clinical supplies and marketed product manufacturing, packaging and labeling; project management; and clinical trials operations. AAIPharma Quality experts are experienced in:

 

  • Sterile and non-sterile facilities
  • CTM and marketed product manufacturing
  • Controlled substances requirements
  • GLP and GMP lab operations
  • US and International GCP operations

 

As a contractor of services to the pharmaceutical industry, AAIPharma 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, GCP and Pre-Approval Inspections.