ANN ARBOR — 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 clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration-regulated industries, specifically medical devices, pharmaceuticals and biologics.
Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, “Good Manufacturing Practices” and “Good Laboratory Practices” testing, certification, R&D and auditing services for the pharmaceutical, dietary supplement and medical device industries.
“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,” said 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,” Johnson said. “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 health care 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:
* Training and education for the pharmaceutical, biotech and medical device industries
* Consulting in quality systems, GMP and compliance/enforcement actions
* Clinical and regulatory consulting
* Analytical testing
* Bioanalytical testing for clinical trials
* Product testing and certification
“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.”