NSF-DBA Dietary Supplements Overview
NSF-DBA Dietary Supplements provides services to the dietary supplement industry, focusing on improving quality systems and increasing the knowledge of your employees, providing custom analytical testing services and assisting companies in meeting regulatory requirements, both in the U.S. and internationally.
At NSF-DBA Dietary Supplements, our consultants and scientists possess extensive knowledge and expertise in both the dietary supplement and pharmaceutical industries. Our team is available to assist you in solving your most challenging dietary supplement quality, method development and regulatory issues.
Our team of experienced professional consultants and trainers can help you improve your competitive edge through:
Operational Excellence Through Quality
We can keep you ahead of your competitors and provide operational improvement through:
- Implementation of cost-effective, compliant quality-management systems.
- Auditing your current operations and assisting with the development and implementation of a supplier qualification program for your operations. This is achieved by auditing your suppliers, for compliance with 21 CFR 111 Good Manufacturing Practices requirements and for benchmarking against current industry best practices.
- Development and training of your staff – at all levels – through industry-leading educational and training programs scheduled throughout the year or through a on-site training specifically customized for your company’s needs.
Speed to Market through Compliance
NSF-DBA help you get your products approved in key international markets as quickly as possible by providing you with world-class consultancy, auditing and training in:
- Product label reviews/translations
- Product registration
- Regulatory/Good Manufacturing Practices compliance
Scope of Our Capabilities
With world headquarters located in Ann Arbor, Michigan, we have more than 80,000 square feet of state-of the-art laboratories, including an extensive array of instrumentation and technologies with a variety of scientists. Our team of highly trained experts includes chemists, microbiologists, assessments. The variety of our experience in working with the dietary supplement industry – combined with exceptional teamwork and customer service – enable NSF-DBA to solve your most challenging undertaking yet. Our capabilities include :
Consulting
Through our extensive network of high-caliber quality, experienced dietary supplement auditors and consultants, we keep abreast of every major industry issue and trend. You can put that knowledge to good use by taking our advice on a broad range of regulatory and technical matters.
Auditing
NSF-DBA can audit your facility, conduct vendor qualification audits, or perform a “Mock” Food and Drug Administration audit to ensure that your operations are meeting the requirements set forth in 21 CFR 111.
Training
Our training is the first of its kind in the dietary supplement industry, in that it is specifically focused on many of the unique issues of quality specific to your company’s operations. Much of the material has been developed with these issues in mind, while also utilizing the work of industry wide guidelines – keeping it current at the same time. The classroom-style education with hands-on exercises allows for plenty of time for discussion specific to your market or company.
Testing Services
Our customized testing services, ongoing investment in new technologies and staff of 100- plus scientists postion our laboratories as leaders in dietary supplement method development, bioanalytical support for clinical trials and performance of stability studies in support of expiration dating on product.
- Method Development
- Stability Storage and Testing
- Bioanalytical Testing Services for Clinical Studies
Regulatory Support Services
Through our global network of regulatory and quality professionals in the dietary supplement industry, NSF-DBA can provide a variety of regulatory support services to meet your organization's needs. Our consultants can conduct regulatory review of labels for compliance to U.S. Food and Drug Administration, Federal Trade Commission and DSHEA requirements and review and translate your product labels to ensure that they are compliant to international (non-U.S.) regulations prior to market entry. Our experts in pharmacognosy and toxicology can provide thorough risk and safety assessments and compile the required documentation for a New Dietary Ingredient (NDI) notification, Generally Recognized as Safe (GRAS) affirmation.
Contact
NSF-DBA Dietary Supplements
789 N. Dixboro Road, Ann Arbor, MI 48105
T: +1 734-769-8010 • F: +1 734-769-0109 • E: [email protected]
