Alachua, Florida (PRWEB) June 19, 2012
Nanotherapeutics announced today that the International Organization for Standardization (ISO) has certified the company in two major areas, an overall quality management system and quality standards for medical devices. ISO is recognized globally for developing and publishing guides for many types of industries and organizations. An ISO certification reinforces the company’s commitment to maintaining the highest standards of quality management and manufacturing.
The company was certified (ISO 9001:2008) for meeting all of the standards for having an effective Quality Management System in place to consistently provide products and services that meet customer and regulatory requirements. “Our goal is to promote customer satisfaction and work towards continually implement and improving processes that will ensure the highest quality we can deliver,” said Dr. Barbel Eppler, Senior Vice President of Quality Assurance.
The second certification (ISO 13485:2003) establishes that the company has specific quality standards for medical device products. Nanotherapeutics manufactures a patented bone void graft product, which it sells in the US and Europe. The product sold under the trade names, NanoFUSE® DBM and SteriFUSE™ DBM Evolved was cleared by the Food and Drug Administration in 2007 and has been consistently produced under current Good Manufacturing Practices (cGMP). The company has successfully passed FDA audits of its cGMP policies and procedures.
“With the successful addition of ISO certification along with our Quality Management System, Nanotherapeutics demonstrates the highest level of management commitment to government and industry regulation and guidance and its commercial partners and customers,” said Dr. Eppler
Nanotherapeutics, Inc. is a privately held biopharmaceutical company with a major focus on developing a diversified proprietary pipeline of products having both biodefense and medical applications. Products under development include biodefense medical countermeasures, CNS, wound healing, addiction and pain, oncology, anti-infectives, vaccines and orthopedics. The Company has one FDA cleared injectable biologic, NanoFUSE® DBM used by orthopedic surgeons as bone graft filler. Nanotherapeutics has in-house cGMP manufacturing, formulation, and expertise in pre-clinical and clinical product development as well as clinical trial management to support its products. Established twelve years ago, the Company employs several proprietary platform technologies to manipulate and enhance the properties of drug candidates. For more information, visit the Company website at http://www.nanotherapeutics.com.