PAREXEL EXPERT SERVES AS LEAD AUTHOR AND EDITOR OF DEFINITIVE RESOURCE ON QUALITY BY DESIGN (QbD), AIMED AT MAXIMIZING PRODUCT QUALITY AND SPEEDING TREATMENTS TO MARKET
Boston, MA, April 11, 2011 — PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, and the Parenteral Drug Association (PDA) today announced the publication of Quality by Design: Putting Theory into Practice, written to help companies maximize product quality and safety. As increasing regulatory pressure is being placed on biopharmaceutical companies to be accountable for Quality Systems, the book serves as a definitive source on the interpretation and implementation of Quality by Design (QbD) approaches. The book features chapters by Lead Author and Editor Siegfried Schmitt Ph.D., Principal Consultant, PAREXEL, as well as other leading experts from the biopharmaceutical industry.
Quality by Design: Putting Theory into Practice addresses not only how compliance can be achieved, maintained and improved but also how it can result in positive financial impact, including reducing the cost of product development. The book outlines key benefits of QbD implementation, including reducing or eliminating the number of reworked batches and drastically reducing product recalls, as well as achieving better manufacturing practices and more robust processes.
“The contributors to this important resource are focused on helping to propel the industry in improving healthcare savings, safety and innovation, while simultaneously providing maximum assurance of product quality. Successful implementation of QbD has the potential to help companies achieve industry leadership,” said Dr. Schmitt. “QbD applied in conjunction with a risk-based compliance approach will deliver cost savings across the lifecycle of a product. The collective expertise of the international group of subject matter experts represented in the Quality by Design compilation offers invaluable information to guide biopharmaceutical companies in emerging regulatory requirements. The book describes how a new level of value can be derived from process understanding and knowledge acquisition in development and manufacturing.”
For more information about the PDA webinar on this topic, to be held April 28, 2011, visit: /company/news-and-events/events/2011/qbd-an-overview-of-qbd-applications-with-some-real-practical-exa/. For more details about Quality by Design, published by PDA and Davis Healthcare International (DHI), and to take advantage of the PAREXEL discount code, visit: http://www.parexel.com/QbD.
# # #
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 52 countries around the world, and has approximately 10,380 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2010 as filed with the SEC on February 9, 2011, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.