August 1, 2006 – Steven M. Niedelman, formerly deputy associate commissioner for Regulatory Operations for the U.S. Food and Drug Administration, has joined Quintiles Consulting as executive vice president, Quintiles Transnational Corp. announced today.
Niedelman, whose 34-year FDA career culminated with responsibility for approximately one-third of all FDA staff, is responsible for all operations at Quintiles Consulting, a leading provider of global regulatory, compliance and validation consulting services to the pharmaceutical, biologics and medical device industries and product development services to the medical device industry.
Niedelman replaces Ron Johnson, who has been appointed to lead The Lewin Group, a nationally recognized health care and human services consultancy that is part of the Quintiles family of companies.
"Steve has played a significant role in shaping and interpreting FDA regulations over the years and brings a wealth of knowledge and insight to our clients at Quintiles Consulting," said Tracy Ken Tsuetaki, President of Quintiles Medical Communications and Consulting. "His management skills and regulatory knowledge add even greater depth to our team of former FDA staff and industry experts who provide guidance to the life sciences industry."
In his most recent role at the FDA, Niedelman served as chief operating officer of the Office of Regulatory Affairs' (ORA's) headquarters offices. At ORA, he assured consistent interpretation and implementation of regulatory policies and oversaw the work of the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations, as well as FDA's 3,400 field staff responsible for investigative and regulatory laboratory field operations. Among his many duties, he co-chaired the FDA's Compliance Policy Council and served as the point person on regulatory and policy issues involving the medical device industry.
Before joining ORA, Niedelman was acting director of the Office of Enforcement, where he had served as deputy director from July 2001 to September 2002. The Office of Enforcement is responsible for developing and assuring compliance to agency policies, processing of enforcement actions, managing recalls, providing information to domestic and foreign governments about the suitability of a firm's ability to provide compliant products and developing and implementing the Quality Management System throughout ORA.
Previously, Niedelman spent 24 years at the Center for Devices and Radiological Health, where he held management positions throughout the Office of Compliance. He began his career with the FDA as a consumer safety officer in 1972 and held positions as an investigator in the FDA's New York District Office and the White Plains Resident Post.
Niedelman graduated from the College of Emporia (Kan.) in 1971 with a bachelor's degree in biology and chemistry. Among the many FDA acknowledgements he has received throughout his career, Niedelman has twice earned the FDA Award of Merit and Commendable Service Award. He also received the first Ronald H. Brown Award from the U.S. Department of Commerce in recognition of his technical assistance to the international medical device community.
About Quintiles Consulting
Quintiles Consulting provides global strategic regulatory consulting in the areas of Quality Systems Development and Optimization, FDA Enforcement Solutions, Validation and Bioresearch Monitoring for the pharmaceutical, biotechnology and medical device industries. Additionally Quintiles Consulting offers global strategies and services for medical device development, including pre-clinical services, clinical trial development and management, reimbursement and U.S. and European Union submissions.
About Quintiles Transnational
Quintiles is the global leader in pharmaceutical services, improving healthcare worldwide by providing innovative, quality professional expertise, market intelligence and partnering solutions to meet the dynamic needs of the pharmaceutical, biotechnology and healthcare industries. Quintiles has 16,000 specialized employees and offices in 50 countries. For more information visit the company's Web site at www.quintiles.com.