GloComply
Start with product facts and target market, then organize regulatory assessment, file preparation, import permits, customs, and logistics.
Food
Exporting food to the U.S. involves FDA food facility registration, a U.S. agent, FSVP importer verification, and label review.
Any facility that manufactures, processes, packs, or holds food for the U.S. market must register with the FDA. We prepare the registration, arrange the U.S. agent appointment, and obtain the registration number; a D-U-N-S Number is required before registration.
Foreign food facilities must designate a U.S.-based agent when registering with the FDA, serving as the point of contact between FDA and the facility. We provide an annual U.S. agent service covering registration support, renewals, and day-to-day FDA correspondence.
A line-by-line review of your label against FDA food labeling rules (21 CFR 101 and related requirements): mandatory declarations, Nutrition Facts, ingredients, and claims — with an action-points document and annotated correction suggestions so the label is compliant before it goes to market.
Build your Foreign Supplier Verification Program file under FSMA (21 CFR Part 1, Subpart L) and receive a per-product verification report covering hazard analysis, supplier evaluation, and verification activity records. Priced per product.
When U.S.-bound food enters without a U.S. owner or consignee, a U.S.-based FSVP agent must be designated to carry the foreign supplier verification responsibility. We act as your FSVP importer agent and coordinate the fulfilment and recordkeeping of the verification obligations.
Pet Food
Pet food and pet treats entering the U.S. require FDA facility registration and labeling, plus USDA APHIS permits when animal-origin ingredients are involved.
Any facility that manufactures, processes, packs, or holds pet food for U.S. consumption must register with FDA and obtain an 11-digit registration number. A D-U-N-S Number and a U.S. agent are required first; we handle the full registration.
U.S. pet food labels must satisfy both FDA federal rules and state requirements generally based on the AAFCO model regulations. We check every mandatory element of your label, deliver an action-point report and a suggested draft, and reduce the risk of detention and warning letters.
FSVP requires U.S. importers to perform hazard analysis, supplier evaluation, and verification for each foreign supplier–product combination and to keep complete records. We build the FSVP file and deliver the verification report; scope is priced per product.
When no U.S. owner or consignee exists at entry, a designated U.S. agent must serve as the FSVP importer. Under appointment, we appear as FSVP importer in entry filings, maintain the verification file, and interface with FDA inspections.
Pet food containing animal-origin ingredients may also need a USDA APHIS Veterinary Services import permit (VS Permit) before entering the U.S. We assess applicability, prepare the application, and follow it through issuance — organized per product, starting from 5 products.
Exporters without a U.S. entity can appoint a U.S.-based Importer of Record (IOR) to clear customs. We review entry elements, file the customs entry, and coordinate FDA release so pet food enters U.S. commerce compliantly.
Commercial imports into the U.S. generally require a customs bond before an entry can be filed. We help you choose between single transaction and continuous bonds, connect you with licensed sureties, and complete CBP filing.
Cosmetics
Cosmetics entering the U.S. require MoCRA facility registration and product listing; the EU requires CPSR, PIF, and CPNP notification; the UK requires UK CPSR and SCPN notification.
MoCRA requires facilities that manufacture or process cosmetics for the U.S. market to register with FDA and renew every two years. Foreign facilities must also designate a U.S. agent. We prepare the filing, submit it, and track renewals.
MoCRA requires the responsible person named on the label to list every cosmetic marketed in the U.S. with FDA, including ingredient information, and update the listing annually. We file each product on your behalf.
A clause-by-clause review of your existing label against FDA cosmetic labeling rules: claims wording, ingredient declaration, mandatory statements, type size and layout. You receive an action-point list and a suggested corrected draft, reducing misbranding risk.
A clause-by-clause check of your formula under the FDA framework: prohibited and restricted ingredients, color additive rules, and standardized nomenclature (INCI). Risk ingredients are flagged, laying the groundwork for label finalization and product listing.
A qualified assessor evaluates your formula: reviewing the toxicological profile of each ingredient and calculating margins of safety against expected exposure, producing a report that supports the safety substantiation MoCRA requires.
Standard organisms are inoculated into the sample and surviving counts are measured at set intervals to verify that the preservative system keeps microbial growth in check over the product's life. Commonly run to USP <51> or ISO 11930, with a report from a partner laboratory.
Accelerated and real-time conditions track changes in appearance, physicochemical, and microbiological indicators over the shelf life, providing the data basis for shelf-life setting, packaging selection, and safety substantiation.
Testing of finished products for total aerobic count, yeast and mold count, and specified objectionable organisms, confirming microbiological quality against U.S. market expectations. Commonly run to USP <61>/<62>.
Instrumental analysis of lead, arsenic, cadmium, mercury, and other heavy-metal impurities in finished cosmetics, assessed against FDA's points of attention on heavy-metal impurities to support safety substantiation and platform compliance.
Evaluates the interaction between formula and packaging over the storage period — whether the packaging deforms or leaks and whether the formula is affected by packaging constituents — providing the basis for packaging selection and shelf-life setting.
Testing of packaging materials for lead, cadmium, mercury, and hexavalent chromium against the limits in U.S. state toxics-in-packaging laws, so non-compliant packaging does not block your launch.
The complete EU market-entry compliance bundle for cosmetics: formula and label review, safety assessment (CPSR), Product Information File (PIF), and CPNP notification in one engagement, with testing coordinated as needed.
The complete UK market-entry compliance bundle for cosmetics: formula and label review, UK safety assessment (UK CPSR), Product Information File (PIF), and SCPN notification in one engagement, with testing coordinated as needed.
Medical Devices
Medical devices entering the U.S. require FDA establishment registration, device listing, UDI/GUDID submissions, and 510(k) premarket notification for many products.
Manufacturers, initial importers, specification developers, and other establishments that intend to market medical devices in the U.S. must complete annual establishment registration with the FDA under 21 CFR Part 807 and pay the annual registration fee. We support classification checks, filing, and annual renewal.
The FDA requires foreign device establishments to designate an agent located in the United States as its routine point of contact. We serve as your U.S. Agent on an annual basis, handling FDA communication, registration maintenance, and inspection coordination.
After establishment registration, every device marketed in the U.S. must be listed with the FDA, declaring its product code, proprietary name, and premarket submission number. Listing is handled per device, and we complete each filing with you.
GUDID is the FDA-administered database for unique device identification and the entry point for UDI data submissions. We help the labeler apply for a GUDID account and configure the basics, paving the way for UDI submissions.
We help the labeler submit each device's DI data to the FDA GUDID database. This service is scoped per group of up to 5 devices, with additional devices arranged separately — suited to first submissions or smaller portfolios.
We review primary and secondary device labels against FDA labeling regulations (21 CFR Part 801 and related rules), flag non-compliances, and recommend corrections — reducing misbranding and port detention risk.
We review device instructions for use (IFU) and user manuals, checking that indications, contraindications, warnings, operating steps, and post-market information align with FDA requirements and your device filings.
The 510(k) is the premarket pathway for most Class II and some Class I devices: demonstrating to the FDA that your device is substantially equivalent to a legally marketed predicate. We support the full project from strategy to clearance.
Companies meeting the revenue threshold can apply for FDA small business certification, unlocking substantially reduced MDUFA user fees for 510(k) and other submissions. We prepare the forms and handle CDRH portal submission.
Company & D-U-N-S
Foundational identity for market entry: D-U-N-S number applications and U.S. company formation (LLC, EIN, business address, bank account).
The D-U-N-S Number is a unique nine-digit identifier for your business. It is required before FDA food facility registration and pet food facility registration. We prepare the application, follow up on verification, and keep your record consistent.
A complete U.S. LLC formation package for exporters: state filing, EIN application, registered agent, physical business address, bank account opening assistance, and essential document templates.
Product compliance and market-entry operations
Leave your product category, target market, and questions. We reply within one business day and help map the next step.
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