SERVICES
Regulatory and Compliance
Stay audit-ready and market-ready, in the U.S. and in the markets you want to enter.
Compliance support from label to export
cGMP readiness
Gap assessments and remediation against 21 CFR Part 111 for dietary supplements and Part 117 for human food.
Audit and inspection preparation
Preparation for third-party certification audits and FDA inspections, including mock audits and support responding to Form 483 observations.
Label and claims review
Supplement Facts and ingredient statements, structure/function claims, required disclaimers and substantiation files, from a reviewer who has examined thousands of supplement labels.
California Proposition 65
Guidance on Proposition 65 exposure assessment and warning requirements.
Export documentation
Certificates of free sale, certificates of analysis, ingredient disclosures, manufacturer and safety declarations, health certificates, notarizations and embassy authentications.
International registrations
Registration support for markets with their own product dossier requirements, such as Brazil, Australia and the European Union.
Bringing product into the U.S.? See Importing Foods and Supplements into the U.S.
Facing an audit, a label question or a new market?
We will help you understand what is required and what to do first.
(631) 901-5164 | info@nutrition50.com