Support for Industry Best Practices and Regulatory Compliance
Consulting For Brand Owners, Manufacturers, Raw Material Suppliers, and others in the Dietary Supplement Industry since 2009
Good Manufacturing Practices
Dietary Supplements 21 CFR 111
General GMPs 21 CFR 117
Labeling 21 CFR 101
SOPs and Document Development
483 & Warning Letter Remediation
Prep for 3rd Party Certification Audits
GMPs for Dietary Supplements
Quality Management for Supplements
GMPs for Dietary Ingredients
Gap Auditing (identifying compliance shortfalls)
Supplier Qualification Audits
GMP Best Practices Coaching
Food Safety Plan Support (§117 HARPC)
Even if you have a Food Scientist or Preventive Controls Qualified Individual at your company, Food Safety Plans are complicated and time consuming. Depending on your processes, we can help. When it comes time for Plan reviews, support is available.
Product Support Documents
No matter whether you are collecting or providing ingredient information, the details and distinctions can be overwhelming. Training or direct assistance is available.
If you are making a dietary supplement, a dietary ingredient,
or a food, your company must address the subject of allergens.
21 CFR 117 - Subpart B requires steps to prevent allergen
cross-contact. Training is one of those requirements.
Link to FDA Allergen information: Allergens
As the work product of industry trade associations, this protocol offers companies an effective, broad-scope way to transfer necessary information about dietary ingredients. No membership or fee is required to use the protocol.
You can transform and streamline the transfer of product information using the SIDI™ protocol and we can help with the document development.
Learn more about the SIDI™ Work Group and the resources for industry at this link: SIDI™
Competent and Reliable Scientific Evidence (CARSE)
is needed to substantiate claims.
It's important to know where to look and what parameters
have weight for the claims you want to make.
The FTC has Enforcement Policies.
If you have questions,
there may be answers for you right now ...
in the FAQs