About Us

Bio Pharma Services Inc. (BPSI) is a physician-owned and physician-run Contract Research Organization (CRO) which specializes in the conduct of Bioequivalence (BE) Studies for generic pharmaceutical companies, and Phase I/IIa clinical trials for innovative pharmaceutical, biotechnology and medical device companies from Europe, US, Canada, Australia, and the rest of the world.  Its service offerings include Clinical Trial Research (Phase I/IIa), Bioequivalence Studies, Pharmacokinetic Analysis, Regulatory Affairs, Data Management, Quality Assurance, Project Management, and Statistical Services. The company was founded in 2006, and it has grown to serve over 30 pharmaceutical and medical device companies globally. The company currently has a state-of-the-art 50,000 square-feet, 174-bed clinical facility based in Toronto, Canada, which has successfully passed inspections by the US FDA, Health Canada, UK MHRA, and numerous customers.  A new bioanalytical laboratory was also recently opened in the Toronto facility, allowing for one-stop shop service for Bioequivalence studies. The company is privately held, and it is headquartered in Toronto, Canada.

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. Announces New CEO

Toronto, ON, Canada September 28, 2011 - Bio Pharma Services Inc. (BPSI) announced that Mr. Renzo DiCarlo has been promoted to Chief Executive Officer effective immediately. Mr. DiCarlo joined BioPharma in February 2011 as Chief Operating Officer.

Previous to BioPharma, Mr. DiCarlo had senior management posts at SNC-Lavalin in Toronto, Canada, and at MDS’ Global Central Laboratory Business in Toronto, Canada, Nordion SA Business in Charleroi, Belgium and Nuclear Medicine Business in Ottawa, Canada.

He leads BioPharma Services Inc. as it celebrates its fifth-year of service, with more than 120 staff members and an established and US FDA-inspected, UK-MHRA inspected, and Health Canada-inspected 158-bed Phase I/IIa and BE study clinical facility in Toronto, Canada, and the opening of a new 120-bed BE clinical facility in Karachi, Pakistan in April, and the planned opening of a new bioanalytical laboratory in Toronto, Canada in October.

“As BioPharma Services’ new CEO, I am proud and humbled to be working for and with our employees, and our clients who are focused on drug development and research. We are a company that values its people, makes a difference in society and expedites medical research.  I am thrilled to be working with the executive team and the Board in continuing to grow BPSI as an early stage drug development success story,” commented Mr. DiCarlo regarding his new role.

Dr. Esmat Dessouki steps down as CEO, but he remains Board Member and Principal Investigator of BioPharma Services Inc.

Bio Pharma's New Bioequivalence Study Clinical Facility Opens

Toronto, ON, Canada January 6, 2011 - Bio Pharma Services Inc. (BPSI) announced that its new 120-bed Bioequivalence (BE) Study clinical facility in Karachi, Pakistan is now open for business.   This facility houses three separate air-conditioned BE study clinics, each with a capacity of up to 40 beds each.  The modern facility was custom-designed by Dr. Masood Bhatti, who also designed and built Bio Pharma’s state-of-the-art 158-bed BE Study clinical facility in Toronto, Canada.

This new BE Study clinical facility in Karachi is operated by Bio Pharma Services Inc., through Bio Pharma Metrics Inc. (BPMI), a newly formed business partnership between Canadian firm Bio Pharma Services Inc., one of the leading BE study Contract Research Organizations in Canada, and Pakistani firm Metrics Research (Pvt.) Ltd., Pakistan's First International Contract Research Organization for Phase I-IV clinical trials.

Bio Pharma Metrics Inc. (BPMI) is Pakistan's First International Bioequivalence Study Contract Research Organization (CRO) geared to serve international generic pharmaceutical companies requiring BE studies for submission to the US, EU, Canada, Australia, and other countries. The site has access to healthy male and female volunteers, and patient populations including cancer patients and schizophrenic patients.  BPMI’s Karachi BE study clinical facility serves as a second site of Bio Pharma Services Inc. for BE studies, complementing the company’s existing 158-bed clinical facility in Toronto, Canada, and increasing Bio Pharma Services Inc.’s total global bed capacity for BE studies to 278 beds. This new facility provides an alternative option to generic pharmaceutical customers of running BE studies in either the Toronto site or the Karachi site.  

The new operation in Karachi has the same high level of quality system, standard operating procedures and training as those in the Toronto headquarters, and it is ready for audits by any governmental regulatory agency such as the US FDA, EMEA, Health Canada, the Pakistani Ministry of Health, and other agencies.   Bio Pharma’s Toronto site has successfully passed inspections by the US FDA, Health Canada and UK MHRA., and by its many clients, and we welcome their inspection of the new Karachi site as well. 

About Bio Pharma Services Inc.:
Bio Pharma Services Inc. is a physician-owned, physician-run, FDA-inspected, UK MHRA-inspected, and Health Canada-inspected Canadian Contract Research Organization (CRO) which specializes in the conduct of Bioequivalence (BE) Studies for generic pharmaceutical companies, and Phase I/IIa clinical trials for innovative pharmaceutical companies from US, Canada, Australia and Europe.  The company currently has a modern 158-bed clinical facility based in Toronto, Canada, and it will be opening another modern 130-bed clinical facility in Karachi, Pakistan by late 2010. It is privately held, and it is headquartered in Toronto, Canada.

About Metrics Research (Pvt.) Ltd.:
Metrics Research (Pvt.) Ltd. is Pakistan's first international Contract Research Organization (CRO)/Site Management Organization (SMO) focused on Phase I - IV clinical trials, with multiple investigator sites available for oncology, infectious diseases, rheumatology, cardiovascular diseases, and other disease areas. It is a privately held company, and it is headquartered in Karachi, Pakistan.

Bio Pharma Services Inc. Successfully Completes UK MHRA’s GCP Audit of Its Clinical Facilities

Toronto, ON, Canada May 6, 2010 - Bio Pharma Services Inc. announced that its Phase I/IIa and Bioequivalence Study Clinical Facilities underwent a successful Good Clinical Practice (GCP) Audit by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on April 16-21, 2010.  The UK auditors spent three days at the Toronto, Canada clinical site for the audit. No critical findings were found following the audit.

This successful UK MHRA audit is a testament to the high quality BE study conduct which European pharmaceutical companies regularly expect from Bio Pharma Services Inc.  It follows the successful audits conducted by the US FDA on March 2009 which had no FDA483 findings, and by Health Canada which concluded GCP compliance from the audit on November 2008.  

Dr. Esmat Dessouki, Bio Pharma's Chief Executive Officer, Chief Medical Officer and Principal Investigator, commented about the UK audit:  "We've done it again. Our staff has demonstrated once more how dedicated they are to quality and reliability of conducting clinical trials for our clients."

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.