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
Early phase programs and generic drug development for human and veterinary applications.
Method development and validation, including biopharmaceuticals
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.