Pharma Focus Asia

BioPharma Services, Inc. Successfully Completes 3 FDA Inspections with ZERO Form 483’s

Monday, May 29, 2017

BioPharma Services, Inc. is proud to announce that it 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, underwent 2 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 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.

“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,” stated BioPharma’s VP of Global Clinical Operations, Louis Co.

“The Bioanalytical audit was a success thanks to our attention to detail and highly skilled and competent laboratory team,” added Nicki Hughes, VP of Bioanalytical Lab Services.

Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs at BioPharma added, "The successful outcome of all three inspections is the direct result of hard work and dedication of our teams! I’m extremely proud of all that we have and continue to accomplish!”

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