About Us

BioPharma Services Inc. (BPSI) is an FDA inspected contract research organization (CRO) that provides Clinical Trials Research (Phases I-IIa), Bioequivalence, Pharmacokinetics, Regulatory, Data Management and Statistical Services to Innovative, Generic Pharmaceutical and Biotechnology companies worldwide. Our 158-bed facility is located in the metropolitan Toronto area, 15 minutes from Toronto Pearson International Airport.

Mission

BioPharma Services Inc. is a contract research organization dedicated to building long-lasting relationships with our clients by providing quality data in a timely and economical fashion through our dedicated experienced professionals.

Bio Pharma Services Inc. Successfully Completes FDA Audit of Its Clinical Facilities Without Any Findings

Toronto, ON, March 6, 2009 - Bio Pharma Services Inc. announced today that its clinical site for Phase I/IIa clinical trials and bioequivalence studies successfully completed an audit by the US' Food and Drug Administration (FDA). The audit was conducted in conjunction with Health Canada's Health Products and Food Branch Inspectorate. No FDA 483 was issued by the FDA auditor.

The audit was a follow up to the first FDA audit of Bio Pharma Services Inc. in February 2008, to confirm that procedural changes which were indicated in the company's official response were in fact executed in subsequent studies. The joint audit focused primarily on two studies. The outcome of the Audit was positive for Bio Pharma Services Inc. since both the FDA and Health Canada completed the week-long audit without any findings.

In November 2008, Bio Pharma Services Inc. also successfully completed a Health Canada audit.

Dr. Esmat Dessouki, Bio Pharma's Chief Executive Officer and Medical Director, stated "The results of this joint FDA-Health Canada Audit is highly satisfactory and sends a clear message to our valued clientele regarding the high quality standards of Bio Pharma's overall operations. Of particular importance was the fact that both regulatory teams complimented management on the changes that had been implemented since the last FDA audit, which occurred in February 2008."

"This is a great accomplishment for all of us at Bio Pharma. which on its second year has completed its second FDA audit with no 483, while larger CRO's have been recently subject to less favourable reviews. This is a testament to Bio Pharma's commitment to continuous improvement and high quality clinical research," added Ms. Lorelei Lutter, VP of Business Development.

About Bio Pharma Services Inc.

Bio Pharma Services Inc. (BPSI) is an innovative, FDA-inspected, and Health-Canada-inspected Phase I/IIa Contract Research Organization (CRO) dedicated to building and maintaining long lasting relationships with clients worldwide by providing superior quality service, timely and reliable research results. Our 158-bed clinical facility is located in the metropolitan Toronto area in Ontario, Canada.

Bio Pharma Services Inc. Successfully passes Health Canada inspection of its clinical facilities

Toronto, ON, Dec 2 – Bio Pharma Services Inc. today reported the favourable outcome from an inspection of its facilities performed by HealthCanada’s Health Products and Food Branch Inspectorate, and completed on November 14, 2008.

The inspection was specific to Good Clinical Practices (GCP), and it was carried out under the authority of Section 23 of the Food and Drugs Act to verify compliance with Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” and any other pertinent Regulation of the said Act.  An overall rating of “C” was given, meaning no objectionable conditions or practices were observed during the inspection.  The inspector audited Bio Pharma’s quality systems, SOPs, as well as a client-specific study.

In February 2008, Bio Pharma Services Inc. also successfully passed an FDA inspection of its clinical facilities.

"I am very proud to announce that Bio Pharma Services Inc. has successfully passed the Health Canada audit of its operations. Coupled with being an FDA audited facility speaks volumes of our staff dedication, professionalism and hard work in their conduct of pharmaceutical industry sponsored clinical trials,”" said Dr. Esmat Dessouki, CEO of Bio Pharma Services Inc.

For more information, please contact
Ms.Lorelei Lutter, Vice-President Business Development, Bio Pharma Services Inc.,
Tel: 416 671 5665, llutter@biopharmaservices.ca.