Know what changed in FDA guidance, and what to do about it.
REdI is an AI tool in development. It will track FDA guidance updates, explain them in plain language, and draft first-pass compliance templates with source citations, for review by qualified professionals.
Email hello@rediregulatory.online
Illustration of the planned output format. This is invented example text, not real FDA guidance.
Sponsors should submit the updated plan within 30 days within 60 days of the change.
Plain-language summary: The submission window grows from 30 to 60 days. The reviewer sees the source passage next to this summary and checks it before use.
What it will do
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Watch FDA guidance
Monitor published FDA guidance documents and flag new and revised ones for your team.
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Explain what changed
Compare versions, summarize the differences in plain language, and note which kinds of products they may affect.
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Draft with citations
Produce first-pass template drafts that point back to the source passage, so a reviewer can check every line.
How it is built
REdI uses Claude, Anthropic's AI model, to read guidance documents, compare versions, and draft text. The first version works only with public documents, such as FDA guidance and published FDA Form 483 observations. It does not need confidential company data.
We plan to test the system on 200 public Form 483 observations from 2020 to 2025 and report how accurate it is, including where it gets things wrong. Every output is meant to be checked by a qualified professional before anyone relies on it.
Where things stand
- Stage
- Idea stage. We are designing the first prototype. REdI is not yet available to customers.
- Founder
- Syed Ashraf Abbas, final-year PharmD student, Bangalore, India.
- Company
- Registration is not yet complete.
- Support
- In November 2025, C-CAMP issued a Letter of Intent to incubate the project if a BIRAC BIG grant is released. No grant has been released.
- Contact
- hello@rediregulatory.online