Dietary Supplements
Expanding dietary supplements into international markets requires compliance with different regulations governing ingredients, formulations, safety, labeling, health claims, manufacturing, registration, importation, and advertising. Requirements can vary significantly from one country to another, making regulatory planning essential before entering a new market.
Globuscertify provides end-to-end regulatory support for dietary supplement brands, helping businesses assess product requirements, review ingredients and claims, prepare compliant labeling and documentation, manage registrations, and navigate import and market-entry requirements across global markets.
What We Offer
We provide practical compliance support across the key regulatory areas that affect food and beverage products entering the U.S. market.
FDA Compliance
Navigate FDA registration, regulatory requirements, product compliance, and U.S. market-entry requirements with expert guidance.
Labelling Compliance
Ensure your product labels meet applicable regulatory requirements for ingredients, claims, warnings, nutrition, language, and mandatory declarations.
Business Registration
Get support with business, facility, product, and regulatory registrations required to operate and enter target markets.
Shipping & Import Compliance
Simplify international shipping with guidance on import documentation, customs requirements, certifications, declarations, and regulatory procedures.
Country-Specific Compliance
Understand and meet the unique regulatory, registration, labelling, certification, and import requirements of each target country.
Implementation Process
Product Assessment
Review the product, formulation, intended use, dosage, and target market to identify applicable regulatory requirements.
Product Classification
Determine whether the product qualifies as a dietary supplement and identify its regulatory category in each target country.
Ingredient & Formula Review
Evaluate ingredients, concentrations, combinations, and restrictions against the regulations of the target market.
Safety & Scientific Evidence
Assess safety requirements and compile appropriate scientific evidence to support product safety and permitted benefits.
Claims Review
Review health, nutritional, structure/function, and marketing claims for regulatory acceptability and supporting evidence.
Testing & Quality Documentation
Identify required testing and prepare quality documents such as specifications, laboratory reports, and Certificates of Analysis (COA).
GMP & Manufacturing Compliance
Verify that manufacturing processes, facilities, quality controls, hygiene, and documentation meet applicable GMP requirements.
Label & Packaging Compliance
Develop or review labels and packaging to ensure all mandatory information, warnings, dosage instructions, and claims are compliant.
Registration & Documentation
Prepare and manage applicable product, facility, importer, notification, licensing, and regulatory documentation.
Import & Shipping Compliance
Address importer requirements, customs documentation, certificates, declarations, and other requirements for bringing the product into the destination market.
Market Entry
Complete the necessary regulatory steps and prepare the product for compliant launch, distribution, and advertising in the target market.
Post-Market Compliance
Maintain ongoing compliance through monitoring, complaint handling, adverse-event reporting, renewals, recalls, and regulatory updates.