🧠 AI Tools for Biotech? Here Are the Questions You Need to Ask Your Vendor About FDA Guidance Compliance
- Sarah Dittmann
- Jul 30, 2025
- 3 min read
Because "powered by AI" means nothing if it's not also grounded in regulatory reality.
As more and more vendors offer AI-powered tools for early-stage biotechs—whether for authoring clinical documents, automating workflows, or flagging regulatory risks—there’s one big question every startup should be asking:
👉 Does this vendor actually understand the FDA regulations that apply to your work?
In too many cases, the answer is “not really.”
We’ve seen AI tools for biotech built on outdated assumptions, AI-generated outputs that contradict current FDA guidance, and companies trying to enter the regulated space with zero experience in it. And while innovation is great, noncompliance isn't.
So how can you tell whether a vendor is truly equipped to support your biotech company in a regulated environment? Here are the top questions to ask before bringing an AI (or any digital) vendor into your regulated workflows:
🔍 1. What FDA guidances are your AI Tools for Biotech designed to align with?
This should not be a trick question. Whether you're using the tool for clinical study reports, IND content, labeling, quality documentation, or anything in between, the vendor should be able to name the relevant guidances they considered during development. If you hear crickets—or generic answers like “we use industry best practices”—that’s a red flag.
🧾 2. Do you have anyone on your team with regulatory affairs or regulatory operations experience?
AI engineers and data scientists are brilliant—but without input from people who’ve worked in regulatory roles, it's easy to miss critical requirements. Look for vendors who’ve built advisory relationships with regulatory professionals or have former FDA/reg ops folks on staff.
📄 3. Can you show how your output aligns with common submission formats (eCTD, CDISC, etc.)?
It’s not enough for the tool to generate “nice-looking” documents. In a regulated setting, formatting, structure, and technical conformance matter. Ask whether the tool accounts for eCTD granularity, Study Tagging Files (STFs), and other technical publishing rules—and whether it has been tested in actual submissions.
🧠 4. How do you prevent hallucinated or noncompliant content?
This is especially important for AI tools that generate scientific or regulatory content. Ask how the system limits hallucinations, whether it cites sources (and if so, how accurate those citations are), and whether there are safeguards to catch regulatory inconsistencies or misstatements.
🧪 5. Has your product been tested or validated in a GxP or submission environment?
Even if full validation isn’t required for your use case, vendors should be able to speak to testing, real-world usage, or user acceptance testing (UAT) in a regulatory context. If you're in a GxP environment, you’ll also want to know whether their software development lifecycle (SDLC) aligns with FDA expectations.
🔄 6. What’s your process for staying up to date with FDA guidances?
FDA guidance changes—sometimes quickly, especially in areas like AI, CMC, and digital health. Your vendor should have a documented process for keeping their tools and content aligned with the latest FDA expectations. Bonus points if they can point to recent updates they’ve implemented in response to new guidances.
🤖 7. How do you stay up to date on different models/model versions?
AI models evolve quickly, and it’s common for vendors to switch or update models on the backend. You’ll want to make sure they have a structured process to determine which model is best suited for a given task and how the company keeps those models up to date.
🤝 8. How do you support your customers during audits or inspections?
If you’re using AI-generated outputs in a submission or GxP context, you may need to defend that content. Ask whether the vendor provides documentation, version history, traceability, or human-in-the-loop review options that can support your inspection readiness.
Final Thoughts
AI is exciting. But in biotech, it's not just about innovation—it’s about fit-for-purpose, compliant innovation. Your vendors should not only understand what you do, but also the regulatory environment you’re working in. And if they don’t? That shiny new tool might end up costing you more in remediation than it saves in time.
Curious about what guidances your vendors should be referencing? Check out our quick guide of Essential Regulatory References for AI Vendors Supporting Small & Start-up Biotechs. 👇
Need help vetting vendors for regulatory readiness?
We’ve reviewed and piloted AI and digital tools across IND, CMC, and clinical documentation programs. Whether you're just starting out or prepping for first-in-human, we can help you choose tools that actually work in regulated biotech. Let’s talk → Contact us or set up a 15-minute chat!
