For more than 30 years, AAIPharma Services has maintained a strong quality and compliance record, which is confirmed by the hundreds of regulator and customer audits and inspections completed each year. We continuously improve and update our quality systems to ensure the highest standards of compliance and performance at every AAIPharma Services facility.

 

We meet all applicable local, state and federal regulatory requirements, including current GMPs and GLPs and country guidelines for the U.S., Canada, EU and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), chemical and pharmaceutical wastes (EPA), child-resistant container-closures (CPSC) and employee safety (OSHA).

 

AAIPharma Services has facilities in strategic U.S. locations to meet client needs across the country. Our headquarters is located in Wilmington, North Carolina, where we recently opened a 40,000-square-foot, state-of-the-art technology center and which features an adaptable lab to provide the flexibility our clients need for their projects.

 

Additionally, AAIPharma operates two cGMP manufacturing facilities: one in Charleston, South Carolina, for parenteral products and one in Wilmington, North Carolina, for oral solid dose. Each is approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and is fully integrated with our packaging and distribution center.

 

We also have cGMP laboratories in Durham and Wilmington, North Carolina as well as in St. Louis and Edison, New Jersey. These facilities and our scientific staff have supported clinical trial supply and commercial programs for decades. Our labs have a strong quality and compliance record and are staffed by dedicated teams of scientists experienced in working with a wide variety of excipients, active pharmaceutical ingredients and drug product forms