PAREXEL CONSULTING STRENGTHENS GOOD MANUFACTURING PRACTICE CAPABILITIES IN EUROPE
BOSTON, MA, September 18, 2007 – PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ: PRXL) and a leading global life sciences consultancy serving the bio/pharmaceutical and medical device industries, announced today that it is strengthening its Good Manufacturing Practice (GMP) capabilities in Europe to help its global client base address complexities of European Union (EU) directives in areas such as manufacturing regulations, quality, and safety.
This initiative includes the addition of three senior consultants to the PAREXEL Consulting team based in Europe. Clive Brading, formerly in a senior Corporate Quality Assurance role at Sanofi-Aventis, has been appointed to the position of Director to lead the PAREXEL Consulting European team of experts focused on strategic compliance and operational process excellence. Dr. Ralf Hess, who served as Chief Scientific Officer for HISS Diagnostics GmbH, and Dr. Siegfried Schmitt, previously a global Quality Assurance Director for Amersham Health (now GE Healthcare), have both been appointed to the position of Principal Consultant.
“As biopharmaceutical companies face intensifying safety obligations, rising operational costs, and the complexities of EU regulations and ICH quality guidelines, they need help to proactively and effectively manage these hurdles,” said Gadi Saarony, Corporate Vice President and Worldwide Head of PAREXEL Consulting. “We are responding to client needs by expanding our established cadre of GMP experts located in Europe, represented by the appointments of Mr. Brading, Dr. Hess, and Dr. Schmitt.”
“Clients rely on our team of specialists for traditional GxP requirements, but also need help with more contemporary challenges, such as maximizing return on investment during post-merger integration, developing robust pharmacovigilance strategies, reducing the risk of counterfeit drugs, implementing ICH quality guidelines, and adopting complex process technologies,” said Clive Brading, Director, PAREXEL Consulting.
Prior to his senior role in Corporate Quality Assurance for Sanofi-Aventis, Mr. Clive Brading held quality and manufacturing positions at a variety of pharmaceutical organizations, both at the corporate and manufacturing site levels. His expertise includes manufacturing and supply requirements in global markets, such as Europe, the U.S. and Japan, and experience with all major pharmaceutical dosage forms. Mr. Brading has served as Chairman of the European Federation of Pharmaceutical Industries Associations (EFPIA) Manufacturing and GMP ad-hoc groups.
As Chief Scientific Officer for HISS Diagnostics GmbH, Dr. Ralf Hess was responsible for research and development of in-vitro diagnostics and regulatory affairs. Previously, he held a post-doctoral research position in the Department of Virology at the University of Freiburg, Germany, where he received a Ph.D. and Masters in Biology. Dr. Hess has been certified as a Quality Control inspector and received certification under German Medical Products Law (MPG). He was recently recognized as Deputy Qualified Person by Swissmedic, the central Swiss supervisory authority for therapeutic products. He is an active member of various societies, including the American Society for Microbiology and the European Society for Clinical Virology.Dr. Hess often presents and publishes on topics related to medical microbiology.
Prior to his position as global Quality Assurance Director in Information Management for Amersham Health, Dr. Siegfried Schmitt was Senior Lead Consultant with ABB Eutech and previously worked as a consultant and validation manager for Raytheon E&C and senior production chemist for F. Hoffmann-La Roche. Dr. Schmitt is a Member of the Royal Society of Chemistry and is a Chartered Chemist and Chartered Scientist. He is also a member of several industry organizations, and was recently elected U.K. Chapter President of the Parenteral Drug Association (PDA). Dr. Schmitt presents at international conferences and he is the editor and author of various books and publications.
Expertise and services provided by PAREXEL Consulting in the areas of strategic compliance and operational performance excellence include:
- Quality strategy for handling complex process technologies
- GxP (Good Laboratory Practice, GMP, and Good Clinical Practice) compliance and inspection readiness for EU and non-EU markets
- Manufacturing planning and site inspection readiness
- Technology transfer
- Pre-approval inspection management
- Post-approval change and file compliance
- Integration of regulatory changes into Quality Systems
- Counterfeit control development
- Manufacturing sourcing strategy
- Pharmacovigilance management and systems
- Development, risk management, and Quality Systems strategy and approaches to ICH* guidelines
- Process and organizational excellence
- Merger and acquisition integration
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* International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
About PAREXEL Consulting
PAREXEL Consulting is a leading life sciences consultancy that helps companies design and execute their biopharmaceutical and medical device product strategies through our unique fusion of scientific, regulatory, and business expertise. Our approach helps clients manage risk, and drives superior quality and performance for clients worldwide. The firm has approximately 270 employees in seven major office locations in the U.S. and Europe, and serves clients on a global basis. For further information visit: www.PAREXELConsulting.com. PAREXEL Consulting is a division of PAREXEL International.
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting 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 56 locations throughout 43 countries around the world, and has 6,485 employees. For more information about PAREXEL International visit http://www.PAREXEL.com.
This release contains "forward-looking" statements regarding future results and events. 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”, “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 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 Annual Report on Form 10-K for the year ended June 30, 2007 as filed with the SEC on August 27, 2007, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this 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 their respective business and are hereby acknowledged.