Regulatory Compliance

Our Regulatory Compliance services ensure your products meet all applicable U.S. and global regulatory standards.
We help you navigate 21 CFR 111, GRAS, NDI, and DSHEA requirements. Whether you’re launching a new supplement or expanding product lines, we clarify what applies and what’s required. Our team reviews product labels, claims, formulations, and ingredients for full compliance. We create or update SOPs and technical files as needed.

You’ll receive strategic guidance and documentation tailored to your product type. We assist with product classification and pathway assessment. We keep up with FDA guidance so you don’t have to. Avoid warning letters, import holds, and costly reformulations. Ensure all claims are substantiated and appropriately disclosed. Streamline your regulatory submissions with expert review and support. Compliance starts here—and we make it seamless.

General Provisions

Establishes scope, definitions, and applicability of Part 111. Details roles and responsibilities within the organization regarding compliance.

Personnel

Personnel must have education, training, or experience to perform assigned functions. Personal hygiene practices must be maintained to contamination.

Physical Plant and Grounds

Facilities must be of suitable size, design, and construction. Prevent pest contamination, ensure sanitation, and manage waste.

Records and Recordkeeping

Maintain documentation for all activities required by Part 111. Retain records for 1 year past product expiration or 2 years beyond distribution.

Product Complaints

Establish a robust product complaint handling system. Thoroughly investigate complaints and maintain comprehensive documentation for FDA review.