FDA Entry Point is a full-stack FDA compliance firm and U.S. Agent, not a mailbox-only or registration-only service. We support foreign manufacturers across food and beverage, cosmetics, medical devices, and drugs and pharmaceuticals, coordinating the U.S. Agent role with registration, product listing, label review, Prior Notice, SPL, GUDID/UDI support, and renewal tracking through one accountable contact.
- $295/year flat-fee U.S. Agent service
- Responses within 24 business hours
- Food, cosmetics, medical devices, and drugs
- One accountable compliance partner
The $295/year fee covers annual U.S. Agent service. Registration, listing, label review, Prior Notice, SPL, GUDID/UDI, and other compliance services are separately scoped and priced unless expressly included in your quote.
More Than a Mailbox: Active U.S. Agent and Compliance Support
Your U.S. Agent should do more than provide an address or forward email. FDA Entry Point serves as your active U.S.-based FDA contact, receives and escalates official communications, coordinates inspection logistics, supports registration and listing workflows, and tracks renewal requirements. When additional filing or review work is required, you continue working with the same specialist team instead of coordinating separate mailbox, registration, labeling, and submission vendors.
- Official FDA Communication and Escalation: We receive FDA correspondence, regulatory notices, inspection requests, recalls, and urgent communications, route them to the right people, and help coordinate the required response.
- Registration, Listing, and Renewal Support: We support facility or establishment registration, product listing, amendments, and renewal tracking according to the requirements and filing cycles for food, cosmetics, medical devices, and drugs.
- Specialized FDA Submission Support: Use the same accountable team for food Prior Notice, drug SPL and NDC workflows, medical-device listing and GUDID/UDI support, and cosmetic facility registration and product listing.
- Label and Claims Review: We offer category-specific label review for food, cosmetics, medical devices, and drugs, including required label elements and claims issues relevant to the applicable FDA framework.
- Specialist Support: Get direct responses within 24 business hours for U.S. Agent, registration, listing, renewal, labeling, submission, and FDA communication questions.
Boutique by Design. Full-Stack in Scope.
Boutique does not mean basic. It means specialist accountability, direct communication, and one team that knows your products and filing history. You receive the responsiveness of a focused firm without limiting your support to a mailbox or one-time registration transaction.
Compliance Support by FDA Category
Explore the specific registration, listing, labeling, and filing services available through the same accountable team, organized by category.
Food and beverage
Cosmetics
- Cosmetic Facility Registration
- Cosmetic Product Listing
- Cosmetic Label Review (INCI)
- Responsible Person Designation