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

AAIPharma Services provides cGMP manufacturing services for clinical and commercial products at its solid dosage and sterile product manufacturing facilities. The facilities located in Charleston, SC (sterile) and Wilmington, NC (solid dose) are comparable in size/staffing and provide flexible capabilities for the processing of a wide range of pharmaceutical drug products, including controlled substances and potent compounds. Clinical manufacturing activity ranges from Phase I through III trials with scale-up and validation support to address commercial launch requirements and to support subsequent commercial supply. Both sites are FDA and MHRA approved and produce products for the US and European markets.

About AAIPharma