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

Formulation Development

You expect proven know-how and timeliness for every development project.

{Our experience and attitude assure both.}

You might hear scientists in our Formulation Development group occasionally say, “Been there. Done that.” It’s not a boast at all, just an assurance that our industry experience and scientific expertise will support your pharmaceutical product development and manufacturing for clinical trial supply and commercial programs. When your project is well established or routine in nature, we’ll move it forward quickly and reliably. When your project presents a unique situation, our experience will pay off in helping you meet the most difficult drug development challenges head on.

Our record and our reputation reflect that we are committed to your project’s success:

  • We have successfully developed formulations used in 100+ IND, NDA and ANDA products.
  • Our staff, including 4 PhD scientists, averages 10+ years of service.
  • We offer solid oral dosage form development and both liquid and lyophilized injectable formulation development.
  • Our team can provide tailored programs in areas such as life cycle management and drug delivery technologies.
  • We have a track record of successful transfer to GMP manufacturing of complex dosage forms.
  • We offer comprehensive services working with a variety of excipient, API and drug product forms.
  • Our full in-house Analytical team is across the hall and has extensive experience to support formulation development.

With every drug development project, count on us to listen to and understand your objectives so we can help you get there.