Consultancy

At NSF-DBA Dietary Supplements, we pride ourselves on our ability to provide rapid, comprehensive and cost-effective recommendations to our clients in a timely manner. Our consultants have more than 500 years of combined experience in the dietary supplement and pharmaceutical industries, assuring practical and balanced guidance.

Consulting

We can provide guidance across a wide range of regulatory and technical issues, including:

• Implementation of cost-effective, regulation compliant quality management systems
• Advice on regulatory and legal issues
• Assistance with responses to regulatory inspection reports, warning letters, etc.
• Troubleshooting on a wide range of technical problems
• Review of validation plans and completed studies
• Regulatory compliance for computers and automated control systems
• Specialist microbiology advice
• Assistance in the development of Standard Operating Procedures (SOPs) as they apply to 21 CFR 111 cGMPs
• Review of existing SOPs as they apply to 21 CFR 111

Auditing

NSF-DBA's auditors and consultants have been auditing the dietary supplement industry's quality and manufacturing operations for years before the Food and Drug Administration released the final rule 21 CFR 111 Dietary Supplement Good Manufacturing Practices in 2007. We have the experience in identifying gaps companies may have against the regulations, while also providing guidance on how to remediate any potential nonconformances. Our auditors can provide a variety of auditing services, including a standard check list-style audit, a full week consultative-type audit to a mock FDA audit. Our auditing and consulting professionals have decades of auditing experience and the expertise to perform audits for any type of activity within the dietary supplement industry. Our capabilities span across processes; from marketing and labeling to contract manufacturing. Our capabilities also span across products; from dietary ingredients to dietary supplement finished products. Our highly qualified staff is comprised of former dietary supplement or major pharmaceutical company senior corporate compliance auditors.

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]