Intensifies Focus on Safer Drugs and Medical Devices
ANN ARBOR, Mich. and WASHINGTON, DC (July 27, 2012) - NSF International, an independent global public health and safety organization which develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting, Inc., a leading clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration (FDA)-regulated industries, specifically medical devices, pharmaceuticals and biologics.
Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, GMP and GLP testing, certification, R&D and auditing services for the pharmaceutical, dietary supplement and medical device industries throughout the entire product lifecycle.
"The partnership between NSF International and Becker comes at a time when the U.S. FDA is actively warning manufacturers and patients about the need for enhanced systems to ensure the safety of medical devices and pharmaceuticals," stated Ron Ginor, M.D., CEO of Becker & Associates Consulting. Dr. Ginor will continue to lead the organization, adding that, "With NSF’s role at the forefront of public health for 68 years and its global capabilities, we will be able to enhance and expand the scope and range of services we can offer to our customers."
Ron Johnson, President of Becker Consulting and former Director of Compliance at FDA’s Center for Devices and Radiological Health, also will continue his leadership of quality systems and compliance activities for the firm, directing the company’s expanding activities in North America, India, China and South America. "The medical device and pharmaceutical sectors are in a period of flux following a number of significant regulatory changes," he stated. "As part of NSF’s Health Sciences Division, we are able to help our clients not only meet FDA compliance but to educate their professionals to stay in compliance by leveraging the vast experience and resources of NSF International."
For more than 20 years, experts at Becker Consulting have helped client companies meet and exceed FDA requirements for developing, testing and marketing innovative healthcare products. They have helped resolve some of the most difficult clinical, regulatory and scientific challenges within the rapidly evolving life science sector. Becker teams operate throughout the world, helping to assure the safety and efficacy of drugs and medical devices, re-establishing manufacturing facilities after natural disasters, designing manufacturing processes for complex biologics, building systems for protecting blood banks, and developing testing protocols and clinical programs for the evaluation of novel drugs and devices, among other roles.
This acquisition complements NSF International’s other health science services to the pharmaceutical, biotech, medical device and dietary supplement industries, including:
"This is a singular opportunity for both NSF International and Becker to expand our global biotech, medical device and life science services," said Kevan P. Lawlor, NSF International President and CEO. "Combining Becker’s market-leading FDA experience with NSF International's unsurpassed training, education, testing and certification expertise will further position NSF as a vital resource in the global pharmaceutical and medical device industries and as a critical partner in the assurance of safer drugs and devices for the public."
About Becker & Associates Consulting (www.becker-consult.com): Becker & Associates Consulting is a prominently recognized life sciences and FDA regulatory consulting firm specializing in innovative healthcare products. Based in Washington, D.C., Becker provides clinical and regulatory consulting services to healthcare companies, their counsel, and investors.
About NSF International's Health Sciences Division (www.nsf.org/business/health_sciences/index.asp): This growing division offers training and education, consulting, GMP and GLP testing, certification, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries throughout the entire product lifecycle. The Health Sciences Division includes: NSF-DBA, which has more than 25 years of pharmaceutical, dietary supplement and medical devices training expertise; NSF Pharmalytica, a GLP & GMP contract laboratory; NSF Reference Standards, supplying pharmaceutical secondary reference standards and NSF Dietary Supplements Certification Program. NSF International developed the only American National Standard for Dietary Supplements (NSF/ANSI 173) and tests and certifies supplements against this standard. NSF's Health Science Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America. NSF International offers ISO 13485 registrations for medical devices and CE Marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Water Division.
About NSF International (www.nsf.org): Based in Ann Arbor, Mich., USA, NSF International is a global independent public health organization that writes standards, and tests and certifies products for food, water, health sciences and consumer goods industries. Established in 1944, NSF is committed to protecting human health and safety worldwide and operates in more than 150 countries. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability, management systems registrations delivered through NSF International Strategic Registrations, and training courses through the NSF Training and Education.