AI in Regulatory Writing: Powerful Ally or Risky Shortcut ?

Here’s what early-stage biotech and pharma teams should know before using AI to help write study reports, CMC docs, or regulatory submissions.

Artificial intelligence (AI) tools like ChatGPT, Claude, and Gemini are quickly becoming common fixtures in life sciences workflows. From protocol drafting to slide preparation, they promise faster output, cleaner prose, and even creative breakthroughs.

But when it comes to clinical and regulatory documents, things get more complicated—and risky.

At The Sugar Water Operations Team, we’re seeing more early-stage teams reach for AI tools to help draft clinical study reports (CSRs), nonclinical summaries, briefing documents, and even sections of their CMC modules. And while AI can absolutely provide value, it’s important to understand the limits and potential pitfalls of using AI in regulatory writing—especially when you’re authoring documents that will land on a regulator’s desk.

Let’s break down the pros, cons, and best practices for using AI responsibly in this space.

✅ The Promise: Where AI Can Help

When used with appropriate caution and procedures in place, AI can:

●        Speed up early drafting: Need a rough outline or want to break writer’s block? AI can quickly draft a high-level structure for a CSR or Module 3 summary giving you a head start.

●        Help with clarity and flow: AI can be great at rephrasing dense text into something more readable (though you’ll still want a human SME to sanity-check it).

●        Summarize large blocks of non-confidential data: If you’re working with a large protocol synopsis or public dataset, AI can help extract key themes or prepare a slide-friendly summary.

●        Brainstorm cover letter or rationale text: AI can help draft background or rationale sections—again, as a starting point, not the final word.

⚠️ The Risk of AI in Regulatory Writing: What You Might Not Have Considered

Despite the hype, AI tools can introduce major compliance and accuracy issues in a regulated environment. Here are a few you might not expect:

●        AI Use may be against company policy Check with your compliance team if you’re unsure of your company’s policy before using AI for any of your tasks. If your company doesn’t yet have a compliance team or a policy, keep reading for considerations to keep in mind.

●        Cited references can be totally made up AI models sometimes “hallucinate” citations—listing real-sounding journal articles that don’t actually exist. If you’re not checking every reference manually, you could be embedding false data into a regulatory submission.

●        Confidential data may be exposed Using a public AI tool (like free ChatGPT or Gemini) to draft a study report could inadvertently expose confidential information. Unless your tool is enterprise-grade and set up to protect your IP, it may not be safe—or compliant. Before using AI tools for tasks involving confidential data, you’ll want to ensure your company has invested in licensing for vetted AI tools – and ideally consulting with a Data Privacy & Security expert to do so.

●        Regulatory nuance can be lost AI tools don’t always understand FDA preferences or ICH conventions. If you let them draft too much, you might miss key expectations (like what belongs in Module 1 vs Module 5, for example).

●        They’re not a substitute for scientific judgment or review AI is helpful, but it can’t replace an experienced scientist, medical writer, or regulatory strategist. It doesn’t know your molecule, your study, or the strategic context behind your messaging.

🧠 Best Practices for Using AI in Regulatory Writing

So how do you balance innovation with compliance? Here’s how we recommend start-up teams approach AI:

1. Use public AI only for low-risk support work

Stick to things like outlining, summarizing public content, or cleaning up grammar. Never use public AI to interpret data or generate submission-ready content without a human in the loop.

2. Always review and verify

Anything AI generates should be reviewed by a qualified subject matter expert—especially if it includes scientific claims, citations, or regulatory language.

3. Don’t paste proprietary data into public tools

Avoid feeding confidential or unpublished content into AI tools that don’t offer secure, enterprise-level protections. When in doubt, check with your IT or Quality lead to ensure everyone is aligned on investment in and usage of AI tools – and consider consulting with a Data Security & Privacy expert to ensure those best practices and requirements have been met.

4. Disclose AI involvement internally

If AI helped generate any portion of a submission-bound document, it should be noted in version control logs or internal document history for transparency. Make sure your SOPs and associated tools are designed with this in mind.

5. Stay Informed

As AI models are evolving rapidly, staying current requires a multi-pronged approach integrating continuous learning, strategic application of AI tools, and a focus on ethical considerations. Subscribe to AI compliance newsletters and regulatory bulletins to stay on top of the latest developments and guidance, and engage with the industry by participating in conferences and working groups on AI ethics and policy to gain insights and share knowledge with peers.

6. Train your team

First, seek training on AI literacy and the use of AI tools in regulatory affairs, focusing on areas like natural language processing (NLP), machine learning (ML), and large language models (LLMs). Then, make sure everyone who uses AI tools understands both the potential benefits and the regulatory risks. A clear SOP can help set expectations and prevent accidental misuse.

The Bottom Line

AI can absolutely help small biotech and pharma teams work smarter and faster—but it can also create regulatory risk if misused. Think of it as a powerful intern: capable of generating drafts and ideas, but not ready to author your Module 2 summaries solo.

By staying thoughtful, reviewing everything carefully, and putting some guardrails in place, you can harness the benefits of AI—without putting your submission at risk.

Need help setting up an SOP for responsible AI use in your organization? Or want support reviewing AI-assisted documents before they go to the FDA?👋 Reach out to The Sugar Water Operations Team or set up a quick call—we’d be happy to help.