BioPharma Services announced it has successfully completed three inspections this month by the FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, Missouri. Over the course of two weeks, the inspections focused on a total of nine studies including four bioanalytical validations that were conducted in support of ANDA and NDA filings to the US FDA. All three inspections concluded without a 483 Form being issued as BioPharma continues to build on its impressive regulatory track history with zero observations.
BioPharma’s US-based clinical facility in Columbia, MO, underwent two sequential FDA inspections with impressive results. Since our opening in 2014, the US-based clinical site has completed a number of pivotal programs to support drug submissions to the US FDA and is poised to undergo a clinical expansion to 120-beds this summer. Following these 3 inspections across both sites, no Form 483s were issued, once again demonstrating BioPharma’s excellence and dedication to quality research.
All inspections were hosted and led by BioPharma’s Senior Management Team, Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs, Louis Co, VP of Global Clinical Operations and Dr. Nicki Hughes, VP of Bioanalytical Operations.
“I am proud of both our teams in Canada and the US for maintaining the highest quality standards in delivering outstanding service to our clients. The dedication of our teams to provide excellent quality and timely service to our clients sets us apart,” BioPharma’s VP of Global Clinical Operations, Louis Co said.