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Regulatory Inspection History

Discover BioPharma Service’s flawless Regulatory Inspection History

Drug development is a highly regulated industry that is governed by the international quality standards of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). BioPharma Services has an unwavering commitment to quality and safety standards and steadfastly adheres to the principles set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We have a long history of regulatory inspections dating back to 2009 with inspections by the US FDA, UK MHRA, ANSM, DKMA, ANVISA, Health Canada, World Health Organization and a GLP certification by the SCC

DateSiteNature of InspectionInspection Report and Response
May 2022TorontoGCP Inspection (Clinic)Zero Form 483 issued
August 2019TorontoGCP Inspection (Lab)Zero Form 483 issued
July 2019Columbia MOGCP Inspection (Clinic)Zero Form 483 issued
August 2018TorontoPre-approval Inspection (Clinic)Zero Form 483 issued
August 2017TorontoPre-approval Inspection (Clinic)Zero Form 483 issued
May 2017TorontoGCP Inspection (Lab)Zero Form 483 issued
May 2017Columbia MOGCP Inspection (Lab)Zero Form 483 issued
May 2017Columbia MOGCP Inspection (Lab)Zero Form 483 issued
December 2015TorontoGCP Inspection (Clinic & Bioanalytical Lab)Zero Form 483 issued
November 2015Columbia MOPre-approval Inspection (Clinic)Zero Form 483 issued
November 2015TorontoGCP Inspection (Clinic & Bioanalytical Lab)Zero Form 483 issued
June 2015TorontoGCP Inspection (Clinic & Bioanalytical Lab)Zero Form 483 issued
August 2012TorontoGCP Inspection (Clinic)Zero Form 483 issued
March 2009TorontoGCP Inspection (Clinic)Zero Form 483 issued
February 2008TorontoPre-approval Inspection (Clinic)Form 483 & BPSI Response Letter issued
DateSiteNature of InspectionInspection Report and Response
January 2018TorontoGCP Inspection (Clinic)Successful Inspection, minor comments
May 2017TorontoControlled Substances InspectionSuccessful Inspection, minor comments
March 2009TorontoFollow up on Good Clinical Practice (GCP) InspectionZero Observations
November 2008TorontoGCP Inspection (Clinic)Inspection Report - BPSI Response Letter Issued
DateSiteNature of InspectionInspection Report and Response
April 2017TorontoInspection of bioequivalence trials for marketing authorization (Clinic & Bioanalytical Lab)Successful completion of GCP Inspection
DateSiteNature of InspectionInspection Report and Response
April 2017TorontoInspection of bioequivalence trials for marketing authorization (Clinic & Bioanalytical Lab)Successful completion of GCP Inspection
DateSiteNature of InspectionInspection Report and Response
November 2021TorontoClinic/Bioanalytical InspectionRecertification received
August 2021St Louis MOClinic InspectionCertificate received
October 2019TorontoBioanalytical & Clinic InspectionRe-certification/Certificate received
November 2017TorontoClinic InspectionCertificate received
October 2017TorontoBioanalytical InspectionRe-certification/Certificate received
August 2015TorontoBioanalytical InspectionCertificate received
DateSiteNature of InspectionInspection Report and Response
November 2018TorontoDesk Assessment
(Clinic & Bioanalytical Lab)
Compliance with WHO GCP & Guidance
DateSiteNature of InspectionInspection Report and Response
August 2019TorontoGCP Inspection (Clinic & Bioanalytical Lab)GCP Inspection Statement received
April 2016TorontoGCP Inspection (Clinic & Bioanalytical Lab)GCP Inspection Statement received
April 2013TorontoGCP Inspection (Clinic & Bioanalytical Lab)GCP Inspection Statement received
April 2010TorontoGCP Inspection (Clinic)GCP Inspection Statement received
DateSiteNature of InspectionInspection Report and Response
March 2021TorontoGood Laboratory Practice (GLP) InspectionGood Laboratory Practice (GLP) Certification (Pending Receipt)
March 2019TorontoGood Laboratory Practice (GLP) InspectionGood Laboratory Practice (GLP) Certification
April 2017TorontoGood Laboratory Practice (GLP) InspectionGood Laboratory Practice (GLP) Certification
February 2015TorontoGood Laboratory Practice (GLP) InspectionGood Laboratory Practice (GLP) Certification

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