Ten Questions to Ask Before Hiring an FDA Consultant

The number of companies offering FDA registration services has grown substantially over the past decade, and the quality varies in ways that are difficult to assess from the outside. For foreign manufacturers — who may be unfamiliar with US regulatory requirements and unable to easily verify consultant claims — hiring the wrong service provider can cause import refusals, registration errors, missed deadlines, and enforcement exposure that costs far more than the service itself. These ten questions are specific enough to surface gaps in experience, accountability, and scope before you commit.

Questions about experience and product knowledge

First: How many registrations have you completed in my product category and country of origin? Any consultant who cannot give a specific number has not worked in your category at meaningful scale. Registration for a low-acid canned food facility differs substantially from registration for an OTC drug manufacturer, and both differ from cosmetic MoCRA filing. Ask for examples of the specific filing type you need. Second: Are you familiar with the program-specific requirements that apply to my products? Beyond general food facility registration, products like low-acid canned foods, seafood, shell eggs, or OTC sunscreens have additional regulatory layers. A consultant who handles all FDA registrations but cannot explain FCE and SID requirements or OMUFA facility fees has not handled complex registrations in those categories.

Questions about the US Agent service

Third: Who exactly will serve as my US Agent, and what is their physical US address? Some registration services list a third-party US Agent from a directory without providing one themselves. Others route FDA communications through an overseas team despite listing a US address. Ask for the specific individual's name, title, and the physical address where they receive FDA mail. Fourth: What is your response time when the FDA contacts the US Agent about my facility? Import holds escalate quickly. A US Agent who responds within two business days instead of a few hours creates a meaningful window for costly port detention. A credible answer is same-day response during US business hours.

Questions about pricing and scope

Fifth: Is the quoted price all-inclusive, or are there separate fees for DUNS acquisition, US Agent service, label review, or renewal submissions? Some providers quote a registration filing fee and charge separately for each adjacent service. By the time the actual registration is complete, the total is significantly higher than the initial quote. A credible provider lists all fees upfront. Sixth: What does renewal cost, and is it included? Drug establishment registrations renew annually; food facility registrations renew every two years. If the initial quote covers only the first filing, you will face another payment cycle within twelve to twenty-four months. Know the total cost of ongoing compliance before committing.

Questions about process and accountability

Seventh: Can you walk me through what happens if the FDA sends a compliance inquiry to my US Agent? An experienced consultant can describe this precisely: the type of inquiry, the response window, what documentation would be needed, and how they coordinate with the client. A consultant who has never managed a compliance inquiry cannot answer from experience. Eighth: What is your process when my registration contains an error? Ask specifically who bears the cost of correction, how long correction takes, and whether the client is notified immediately when an error is discovered. Ninth: How long has your company been providing FDA registration services? A firm operating for fewer than three years has not experienced a full biennial food facility renewal cycle or the consequences of a missed drug establishment re-registration window. Longevity is not a guarantee of quality, but it is a baseline data point. Tenth: What happens to my registration if I stop paying, or if your company closes? If the service provider also serves as US Agent, their operational status directly affects your regulatory standing. Ask how US Agent records are transferred if the relationship ends, and whether you have direct access to your FDA submission records at any time.

How FDABridge answers these questions

FDABridge provides specific answers to every one of these questions before a client commits. Our US Agent service is staffed by US-based compliance professionals with same-business-day response to FDA communications. All fees — registration, DUNS, US Agent, and renewal — are quoted together. Clients have direct access to their FDA submission records through our client portal. Visit fdabridge.com/contact to discuss your registration needs, or fdabridge.com/pricing to compare service packages.