Ronald Kershner Appointed to Lead AAIPharma’s N. American Biostatistics and Data Management Services
Ronald Kershner joins AAIPharma to lead the Company’s North American Biostatistics and Data Management Services groups. Ronald brings over 25 years of industry experience at various large pharmaceutical, biotechnology and Contract Research companies. In previous roles with inVentiv, Inveresk and Omnicare, Ronald was responsible for the oversight of biostatistics and data management across a variety of therapeutic areas. Ronald brings significant experience with regulatory submissions and FDA interactions and has been involved in over 20 NDA submissions.
AAIPharma received certification that the company’s operations are in compliance with EU Good Manufacturing Practice regulations
AAIPharma has received its second certification from a European Union (EU) regulatory body that the company’s operations are in compliance with EU Good Manufacturing Practice (GMP) regulations. Following an audit of AAIPharma’s manufacturing, testing and stability operations located in Wilmington, North Carolina, USA, Sweden’s Medical Products Agency (MPA) notified the company that tablet, capsule and other solid dose drug manufacturing and testing operations can be certified as meeting EU GMPs.
