BioPharma Services’ tradition of clinical research distinction continues with the successful completion of another FDA inspections. Over the last few weeks, our clinical site in Columbia, Missouri as well as the Bioanalytical Laboratory in Toronto, Canada, have been audited by the US federal agency without any critical findings or issuance of Form 483s. The GCP pre-approval inspections focussed on several clinical studies which were recently submitted to the USA FDA for approval.
Since 2009, the FDA has conducted 13 GCP Inspections of BioPharma Services without a single Form 483 issued. With over 1800 clinical studies completed to support drug submissions to all major markets, this is yet another milestone achievement in BioPharma’s 13-year history. Our facilities in Canada and USA have also been successfully inspected by a number of regulatory agencies including the UK MHRA, EMA, Health Canada, and ANVISA (Brazil). BioPharma is also one of the few North American CROs to be certified by the World Health Organization.
Renzo DiCarlo, CEO remarked, “It truly is our people that differentiate BioPharma Services from other CROs. We are very proud today to share this exceptional track record of successful inspections with our clients and to recognise the dedication and hard work of our associates who strive for excellence every day”.
Andjica Tasic, VP of Global Quality Assurance further commented, “Passion, integrity and unwavering commitment to quality are the hallmarks of the BioPharma Services team, which has resulted in this impressive record of inspections. It is our people combined with our client-focused, client-centric approach that has enabled us to become a global leader in the CRO space”.
About BioPharma Services Inc.
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.
Ms. Anna Taylor, Executive Vice President, Business Development, BioPharma Services, Inc.
Main Telephone: +1 844 747 8484