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FDA Entry Point
Case studyRegulatory compliance

How Changing AI’s Mind Transformed FDA Entry Point’s Inbound

FDA Entry Point helps foreign manufacturers with FDA registration and U.S. Agent services, and its buyers increasingly rely on AI to discover and evaluate providers. In July, AI assistants mistook the company for a government system. By the fall they recommended it by name, and inbound followed.

Marty Coleman

Marty Coleman, CEO, Second Wind

Inbound inquiries per month

1-3

Before Second Wind

July 2026

10+

With Second Wind

October 2026, and climbing

Visibility: how often each assistant mentions or cites FDA Entry Point when buyers ask about the category, from kickoff (July 7, 2026) to October 8, 2026. Largest platform gains shown.

ChatGPT logo
ChatGPT
9xmore often
Gemini logo
Gemini
8xmore often
Grok logo
Grok
5xmore often

“Before we started with Second Wind we were getting 1-3 inquiries a month, and now we’re getting 10 or more. We have seen incredible results that can be directly attributed to the work they do. It’s been an incredible boost to our business.”

Dave N. and Lydia N., Co-founders, FDA Entry Point
01

AI didn’t know they were a company

FDA Entry Point helps foreign manufacturers of food, cosmetics, drugs and medical devices register with the FDA and meet U.S. Agent requirements. Its buyers are regulatory and operations teams at overseas companies, and more of them now build a vendor shortlist by asking an AI assistant who to hire.

In July, the assistants described FDA Entry Point as part of the FDA. When buyers asked them to compare providers, they treated it as a government submission channel and left it off the list.

What does FDA Entry Point do?
Perplexity logoPerplexityJul 7
“The FDA does not have a single function called ‘FDA Entry Point’; rather, the Entry Review process… determines whether FDA-regulated products are admissible into U.S. commerce…”

Mistaken for a government process. The company didn’t exist to AI.

Perplexity logoPerplexityOct 8
“FDA Entry Point is a private FDA-compliance firm, not a government agency. It serves as the U.S.-based point of contact for foreign manufacturers of FDA-regulated food, cosmetics, drugs, and medical devices, handling FDA communications and helping with registrations, product listings, renewals, and relabeling.”

Correctly identified, with its full service line described.

FDA Entry Point vs Registrar Corp for OTC drug manufacturers that need SPL submission support
ChatGPT logoChatGPTJul 7
“Registrar Corp is the service provider and FDA Entry Point/FDA systems are the government submission channels, not a consulting alternative.”

Written off as a government submission channel.

ChatGPT logoChatGPTOct 8
“FDA Entry Point: likely better if you want a more hands-on, boutique service model and direct help navigating SPL work. Registrar Corp: likely better if you want a larger, more established compliance vendor…”

Recommended head-to-head against the category leader.

By the fall, AI described FDA Entry Point as a strong specialist firm and recommended it against the category leader to the buyers it serves best.

All four answers quoted verbatim from tracked responses. Each pair is the same question to the same assistant on Jul 7 and Oct 8.

02

What we did

Every week, our platform tested how 7 major AI platforms (ChatGPT, Gemini, Claude, Grok, Perplexity, Google AI Overviews, and AI Mode) answered FDA Entry Point’s buyer questions across thousands of responses, and analyzed where the company was missing, described wrongly (or unfavorably), or losing to a competitor.

Based on the findings, the Strategy Agent rebuilt how AI understands the company. Second Wind deployed auto-updating agent-facing reference infrastructure that gives agents the evidence and use case information they need to confidently recommend FDA Entry Point for its buyers’ specific compliance needs.

Most of FDA Entry Point’s buyers are outside the U.S., and many research in their own language. We published targeted variations of that infrastructure in eight languages, so a manufacturer asking in its own language can get an informed recommendation backed by the same detailed evidence.

Beyond their owned content, the Strategy Agent identified the highest-value actions across the wider web, where AI forms its view of the category, and FDA Entry Point’s team acted on them.

03

Winning the “who should I hire” moment

The biggest shift came on the questions buyers ask right before they pick a provider.

5x

as many high-intent hiring questions now get an AI answer that names FDA Entry Point, usually in the top 3.

Showing up in far more answers

Share of AI answers that name or cite FDA Entry Point, October vs. July

64%2.4x

up from 27% in July

“Where can I get cosmetic label review and U.S. Agent support in one place?”

50%4.5x

up from 11% in July

“Best U.S. Agent for FDA food”

50%4x

up from 12% in July

“Which U.S. Agent is right for a company replacing a mailbox-only FDA agent?”

42%5x

up from 8% in July

“Who helps companies switch from registrar-style FDA agent service to full compliance support?”

All tracked AI assistants (ChatGPT, Gemini, Claude, Grok, Perplexity, Google AI Overviews and AI Mode). July pools the first four runs; October pools the Oct 1 and Oct 8 runs.

04

Closing in on the category leader

Registrar Corp is the established name in FDA compliance. At kickoff in July, when a buyer asked AI a question without naming any company, AI named or cited Registrar Corp 30 times as often as FDA Entry Point on our tracked set. By October that edge was down to 1.3x.

30x→1.3x

How much more often AI named or cited Registrar Corp than FDA Entry Point on tracked unbranded buyer questions.

#90→#5

FDA Entry Point’s rank among every source AI cites on unbranded buyer questions, government sites like fda.gov included.

Unbranded buyer questions only (no company named), across ChatGPT, Gemini, Grok, Perplexity and Claude. A company counts when AI names or cites it. Kickoff (Jul 7) vs. latest run (Oct 8).

Your buyers are asking AI who to hire. Is it sold on you?

AI agents now sit in on your buyers’ purchasing decisions. Second Wind makes your case to those agents, so you’re the provider they recommend when it’s time to choose.

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