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

Manufacturing Services

Whether you need solid dose or sterile, clinical or commercial, you always need a reliable manufacturer.

{We have proven experience and expertise.}

Your needs may vary or change, but your demand for quality and dependability should remain steadfast. Our cGMP manufacturing facilities are located in Charleston, South Carolina, for parenteral products and in Wilmington, North Carolina, for solid oral dosage forms. We provide flexible capabilities for processing a wide range of pharmaceutical drug products, including controlled substances and toxic or potent compounds. Our facilities are approved by the USFDA and EMA and produce products for your clinical and commercial supplies in US and European markets. AAIPharma Services has manufacturing expertise in:

  • Clinical manufacturing activity that ranges from Phase I-III trials, with scale-up and validation support to address commercial launch and supply
  • DEA-compliant Schedule I-V controlled substances
  • Level 3 and 4 toxic/potent compounds
  • Difficult-to-make products
  • Commercial niche products such as orphan and veterinary drugs
  • Sterile products for small molecules and biologics, including proteins, peptides, monoclonal antibodies and other large molecules

What’s more, our manufacturing services integrate seamlessly with our packaging and distribution facility. It’s one more way we make the manufacturing experience better for you.