BioPharma Services completes 3 FDA Inspections at both the research centers

BioPharma Services has successfully completed 3 inspections this month by the US FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, Missouri.

Over the course of 2 weeks, the back-to-back inspections focused on a total of 9 studies including 4 bioanalytical validations that were conducted in support of ANDA and NDA filings to the US FDA.  All 3 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 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 3 inspections were hosted and led by BioPharma’s Sr. 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.  Under their leadership and direction, BioPharma continues to lead the industry in quality, innovation, and cost effectiveness.

BioPharma’s VP of Global Clinical Operations, Louis Co said that he proud of both of their teams in Canada and the US for maintaining the highest quality standards in delivering outstanding service to their clients. The dedication of their teams to provide excellent quality and timely service to their clients sets them apart.

Bioanalytical Lab Services VP, Nicki Hughes said that the Bioanalytical audit was a success thanks to our attention to detail and highly skilled and competent laboratory team. Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs at BioPharma further added that the successful outcome of all three inspections is the direct result of hard work and dedication of their teams! He is  extremely proud of all that they have and continue to accomplish!