Formulation
Development
  • Formulation
    • Preformulation
    • Characterization
    • Stability Studies
  • Biopharmaceutical
Analytical
Chemistry
Manufacturing
Services
  • Formulation & Scale-Up
    • Process Scale-Up
    • Process Validation
    • Investigational Supplies
    • Clinical Supplies
    • Commercial Supplies
Packaging
& Distribution
  • Clinical Packaging
    • Design Support
    • Kitting
    • Debulking and Overpacking
    • Device Assembly
    • Manual & Semi-Automated Solid Dose Bottle Filling
    • Thermoform/Coldform Blisters
    • Secondary Packaging
  • Clinical Labeling
    • Label Development & Proof
    • Randomization & Blinding
    • Multi-Lingual Open & Blinded Labeling
  • Commercial Packaging
    • Packaging of Vials, Bottles, & Blisters
    • Repackaging of Commercial Products
    • Label Development & Labeling
    • Cartoning
    • Inventory Management
  • Global Distribution
    • Controlled Storage
    • Validated Shipments
    • Reconciliation/Destruction
Support
Services
  • Stability Management
    • Stability Study Design
    • Stability Trending
  • Stability Testing
  • Regulatory Support
    • Strategy Consultation & Guidance
    • Full CMC Services
    • Agent Representation
    • Liaison Activities
    • Global Experience
ABOUT AAIPHARMA

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. 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 USFDA, formulations 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.