Food & Dietary Supplement Regulatory Services

DSHEA Compliance Assessment (Dietary Supplement Health and Education Act)

We evaluate your supplement products against DSHEA requirements to ensure ingredients, labeling, and claims fall within lawful parameters for the U.S. market.

New Dietary Ingredient (NDI) Notification — 21 CFR 190.6

We prepare and submit NDI notifications to FDA for ingredients introduced after October 15, 1994, establishing their safety for legal marketing in the U.S.

FDA Dietary Supplement Facility Registration & Renewal

We handle facility registration in FDA's systems for supplement manufacturers, packers, and distributors, ensuring timely biennial renewals under 21 CFR Part 1.

cGMP Compliance for Dietary Supplements (21 CFR Part 111)

We conduct gap analyses, mock inspections, and documentation reviews to prepare your facility for FDA cGMP audits specific to dietary supplement manufacturing.

Supplement Facts Panel Review & Labeling Compliance (21 CFR 101)

We design and audit Supplement Facts panels for full compliance — serving size, nutrient declarations, daily values, and mandatory label statements.

Structure/Function Claims Substantiation & FDA Notification (21 CFR 101.93)

We draft defensible structure/function claims backed by competent scientific evidence and file the required 30-day notification with FDA.

FDA Food Facility Registration — FSMA Compliance (21 CFR Part 1, Subpart H)

We register your food manufacturing, processing, or storage facility with FDA as required under FSMA's Preventive Controls rules.

FSMA Preventive Controls Compliance (21 CFR Part 117)

We develop and review Food Safety Plans, Hazard Analysis, Preventive Controls, and monitoring records to ensure FSMA Preventive Controls compliance for human food.

Ingredient Safety Review & GRAS Determination Support

We assess ingredient safety, evaluate GRAS (Generally Recognized As Safe) status, and support self-affirmation or FDA GRAS notification submission pathways.

Adverse Event Reporting for Dietary Supplements (CFSAN AER System)

We implement procedures for mandatory serious adverse event reporting to FDA as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

Health Canada Natural Health Product (NHP) Product Licence Application

We prepare complete product licence applications for natural health products under Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD).

Health Canada NHP Site Licence Application

We manage site licence applications for NHP manufacturers, packagers, importers, and distributors under Health Canada's Natural Health Products Regulations.

Health Canada NPN / DIN-HM Strategy & Submission

We develop regulatory strategies and prepare submissions to obtain Natural Product Numbers (NPN) or Homeopathic Medicine numbers (DIN-HM) for your products.

Dual-Market Strategy — FDA + Health Canada Simultaneous Compliance

We align documentation, claims, and timelines to pursue both FDA and Health Canada compliance in parallel, accelerating your path to market in both countries.