AAIPharma has supported over 500 Investigational New Drug (IND) filings and over 50 New Drug Applications (NDA),  Abbreviated New Drug Applications (ANDA) and New Animal Drug Applications ( NADA) over the past 30 years. AAIPharma specializes in all phases of pharmaceutical development – from critical preformulation studies to commercial product life-cycle management. Our comprehensive services are fully integrated to help our clients get the most out of their portfolio.

Our comprehensive pharmaceutical product development services include:

  • Early phase clinical trial material formulation development
  • Analytical method development and validation
  • Biopharmaceutical analytical development and validation
  • Clinical trial material (CTM) manufacturing
    • Oral solid dose manufacturing
    • Sterile / aseptically processed manufacturing
  • Packaging, labeling and distribution
  • Stability storage and testing
  • Regulatory affairs support
  • Project management
Formulation Development

Formulation Development

Early phase programs and generic drug development for human and veterinary applications.

Analytical Chemistry Services

Analytical Development

Method development and validation, including biopharmaceuticals

Stability Testing

Stability Storage & Testing

AAIPharma conducts more than 200 stability studies a year – with full ICH and custom storage conditions

Contact us for more information about our Product Development services.