TORONTO--(BUSINESS WIRE)--BioPharma Services Inc. (BioPharma) is proud to announce that it has once again successfully completed inspections by the US FDA, with concurrent audits at both of the Phase I/IIa clinical sites in Toronto, and Columbia, MO.
“The successful outcome of all three inspections is the direct result of hard work and dedication of everyone at BioPharma as well as our commitment to upholding the highest quality standards in conducting clinical trials at our facilities in Canada and USA!”
With back to back audits of the clinical facilities and bioanalytical laboratory in Toronto, BioPharma continues to build an impressive regulatory track record, having now completed 6 successful FDA inspections at their parent location.
BioPharma’s US-based clinical site in Columbia, MO underwent a simultaneous FDA inspection, with equally impressive results. Since it’s opening in 2014, the US-based clinic has completed a number of pivotal studies for submission to the US FDA. This inspection marks a critical milestone for the organization as the first-ever regulatory inspection for the US site.
Following all three inspections across both sites, no Form 483s were issued, once again demonstrating BioPharma’s excellence and dedication to quality research. These inspections add to the long list of BioPharma’s outstanding audit history with USA FDA, UK MHRA, Standards Council of Canada, Health Canada and ANVISA.
“This is a significant milestone for our USA site in Missouri as this was their first FDA audit and I am proud of both our teams in Canada and USA for maintaining the highest quality standards in delivering outstanding service to our international clients. The dedication of our teams to provide excellent quality and timeline oriented service to our clients is what makes us so successful!” stated BioPharma’s CEO, Renzo DiCarlo.
Andjica Tasic, Sr. Director of 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 everyone at BioPharma as well as our commitment to upholding the highest quality standards in conducting clinical trials at our facilities in Canada and USA!”
About BioPharma Services Inc.
BioPharma Services Inc. is a Full-Service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide. The company has clinical facilities both in the U.S.A. and in Canada with a total bed capacity of 250 with access to healthy volunteers, special populations and patients. Headquartered in Toronto, Canada, BioPharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.
www.biopharmaservices.com
Info@biopharmaservices.com
Contacts
BioPharma Services, Inc.
Ms. Anna Taylor, 1-844-747-8484
Senior Director, Business Development
ataylor@biopharmaservices.com
