Support for Industry Best Practices and Regulatory Compliance

Consulting on Dietary Supplements & Food Ingredients

Consulting Services for Industry

Services to Fit Your Needs

Dietary Supplements

Consulting For Brand Owners, Manufacturers, Raw Material Suppliers, and others in the Dietary Supplement Industry since 2009

Regulatory Support

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

Training, Auditing, & Coaching

GMPs for Dietary Supplements 

Quality Management for Supplements

GMPs for Dietary Ingredients

Gap Auditing (identifying compliance shortfalls)

Supplier Qualification Audits

GMP Best Practices Coaching

Find out More

Food Additives & Dietary Ingredients

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.

Allergen Controls Training

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

SIDI™ Style Documentation

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™ 

Need to Collect Competent and Reliable Scientific Evidence?

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

Answers to Frequently Asked Questions