Quintiles Consulting Further Strengthens Its Regulatory and Quality Capabilities

RESEARCH TRIANGLE PARK, N.C. -- (BUSINESS WIRE) -- Quintiles Consulting today announced three key appointments in its US Regulatory and Quality consulting practice. These new appointments expand Quintiles’ experience in regulatory compliance and quality system development. They also bring industry-leading expertise to the table to help clients navigate a rapidly changing regulatory environment and fully optimize the development of a new drug, biologic or medical device.

“Our customers are facing intense pressure in the marketplace due to ever-increasing scrutiny by regulators and public demand for quality products,” said Geoff Garabedian, Vice President and Managing Director for the Regulatory and Quality practice. “With these new appointments, Quintiles’ Consulting practice offers a uniquely experienced global Regulatory and Quality consulting group to drive our clients’ success. Our exceptional understanding of regulatory and compliance environments, combined with our strategic advice and operational counsel, can build clients’ competitive advantage in the regulatory and quality sectors.”

• Bob Rhoades joins Quintiles Consulting as Head of the Quality Systems business units (bio/pharma and device) within the United States. Bob brings more than 30 years experience in regulatory compliance, Quality System Regulation (QSR) and the pharmaceutical Good Manufacturing Practices (GMPs), with expertise designing and implementing compliance improvement initiatives for major manufacturers in the US, Europe and China. Bob has authored numerous articles on quality-related topics as well as the book, “Risky Business: Managing the Quality of America’s Medicines,” which was released in February 2004 by FDANews, and is now in its second edition. His second book, “Sustaining Compliance: Strategies for Maintaining Drug Quality,” was released in July 2005. Bob holds an MBA, Operations and Strategic Planning, from Lake Forest Graduate School of Management and a B.S., Microbiology, from Purdue University.
• Michael Swiatocha joins Quintiles Consulting as Head of the R&D Compliance business unit, focusing on clinical and non-clinical research activities for device and pharmaceutical companies to ensure compliance with applicable regulations and guidelines. Michael joins Quintiles from Schering-Plough Corporation where he served as Vice President and Compliance Officer for the Schering-Plough Research Institute. Prior to that, Michael was a Director in the Global Pharmaceutical and Health Sciences practice at PricewaterhouseCoopers LLP where he concentrated on the development and implementation of strategic compliance, ethics and risk management programs at life sciences companies. Michael brings more than 25 years experience in the life sciences industry and has held management positions in compliance, regulatory affairs, clinical research, manufacturing, quality and sales. Michael holds an M.S. degree in Medical Biology from Long Island University and a B.S. degree in Psychology from Fordham University. He has been a frequent speaker on drug and device industry compliance issues for the Pharmaceutical Compliance Forum and the National Congress on Health Care Compliance.
• Barbara (Jan) Holladay Pierre has joined the Quintiles Consulting BIMO group as a Principal Consultant. Jan is based in the Rockville, Md., office and will be working with foreign and domestic clients in the pharmaceutical, medical device and biotechnology industries to develop quality assurance and regulatory strategies for compliance. Jan brings to Quintiles more than 10 years experience in clinical research, with a unique combination of expertise in inspections, regulatory compliance, auditing, quality assurance and training. She is a former member of FDA Foreign Inspection Cadre and former FDA investigator, with more than six years experience auditing/inspecting sponsors, IRBs, clinical investigators, manufacturers and non-clinical laboratories. Jan holds an M.P.H. in International Health Policy from George Washington University and a B.S., International Relations, from Florida State University.

About Quintiles Consulting

Quintiles Consulting works with pharmaceutical, biotech and medical device companies to maximize potential and minimize risk, from discovery through development and commercialization by providing expert strategic, operational, and technical advice. Building on the global reach and expertise of Quintiles Transnational, Quintiles Consulting practice areas include Product Development and Commercialization, Regulatory and Quality, Market Intelligence and Market Access. For more information, please visit www.quintiles.com/consulting.

About Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.