NSF International Acquires Leader in Pharmaceuticals and Biotechnology

February 16, 2011

NSF Pharmalytica to provide expanded service offerings to the pharmaceutical, biotech and medical device industries

ANN ARBOR, Mich. and BRISTOL, Conn. — NSF International, an independent public health organization offering dietary supplement training, Good Manufacturing Practices (GMP) registration, testing and certification services, has acquired Pharmalytica Services, a pharmaceutical contract laboratory based in Connecticut.

Pharmalytica provides a full range of GLP & GMP analytical services to the pharmaceutical and biotechnology industry from discovery support through commercialization. Pharmalytica specializes in extractables and leachables testing, method development and validation, and bioanalysis. Services provided by Pharmalytica’s Food and Drug Administration (FDA)-registered and Drug Enforcement Administration (DEA)-licensed facility complement the extensive health sciences services offered by NSF International to global pharmaceutical companies.

NSF International’s Health Sciences Division currently offers certification, training, consulting and GMP auditing in the areas of pharmaceuticals, dietary supplements and medical devices through NSF and NSF-DBA, an NSF International Company. Formerly known as David Begg Associates, NSF-DBA has 25 years of pharma industry expertise, including offering the Quality Leadership Program for pharmaceutical professionals.

Additionally, NSF developed the only American National Standard for Dietary Supplements (NSF/ANSI Standard 173) and certifies dietary supplements to this standard to verify label claims and that a product is free of undeclared substances and unacceptable levels of contaminants. The NSF Certified for Sport® program builds on the NSF Dietary Supplement Certification program by including banned substances screening to minimize the risk that a dietary supplement or sports nutrition product contains banned substances.

As part of NSF’s Health Science Division, NSF Pharmalytica will provide analytical testing, consulting, training, registration and research and development (R&D) services, expanding NSF’s health sciences service offerings to the pharmaceutical, biotech and medical device industries. Pharmalytica will operate primarily as a GLP & GMP contract laboratory, offering a wider array of independent testing and analytical services. Pharmaceutical, medical device and biotechnology companies will benefit from these combined services, which are essential as the dietary supplement and pharmaceutical markets continue to grow globally.

"Combining Pharmalytica’s knowledge in pharmaceutical analytical testing and R&D with our existing portfolio of dietary supplement and pharma solutions will help pharmaceutical companies worldwide make informed decisions when developing new products and strategies," said NSF International CEO and President Kevan P. Lawlor.

"We have great confidence that Pharmalytica’s expertise, in synergy with NSF’s 65 years of testing and certification expertise, will be of great benefit in the development of new medicines worldwide," said Dr. James Scull, Executive Director of Pharmalytica Services, LLC.

About NSF International: NSF International, an independent, not-for-profit organization, certifies products and writes standards for food, water, dietary supplements and consumer goods to minimize adverse health effects and protect the environment (www.nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional NSF services include sustainability services through NSF Sustainability, management systems registrations delivered through NSF International Strategic Registrations (NSF-ISR) and NSF Education and Training programs.

NSF’s Health Sciences Division offers certification, training, consulting, testing and auditing for the pharmaceutical, dietary supplement and medical device industries through NSF and NSF-DBA, an NSF International Company with 25 years of pharma experience. NSF International developed the American National Standard for Dietary Supplements (NSF/ANSI Standard 173) and test and certifies supplements against this standard via the NSF Dietary Supplements Certification Program. NSF operates globally throughout North America, Europe, Middle East, Africa, Asia and Latin America.

About Pharmalytica Services: Pharmalytica Services is a GLP & GMP contract laboratory specializing in extractables & leachables testing, method development and validation, medical device compatibility and bioanalysis (www.pharmalytica.com). Pharmalytica provides services to pharmaceutical, medical device and biotechnology companies developing a wide array of treatments in a variety of delivery devices and packaging configurations.

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