- Enterprise h2oGPTe can draft sections of periodic safety reports from your approved safety data and documents, with a citation to the source behind each statement.
- An agent can check a submission package against your own table of contents and flag missing sections or numbers that do not match across documents.
- H2O Document AI can pull tables and fields from source reports into structured data your writers can reuse.
- H2O makes no claim of GxP, 21 CFR Part 11 or FDA validation: the platform supports validated workflows, the validation is yours, and a qualified person signs every document.
Your writers spend the cycle finding sources, not writing
A periodic safety report or a submission module draws on case data, study reports, prior submissions, labels and correspondence stored in different systems. Your medical writers spend much of each cycle finding the approved version of each source and copying numbers across.
Consistency is the next risk. A dose, a case count or a date that differs between two sections becomes a question from a health authority, and checking a large package by hand is slow. Health authority letters, guidance updates and commitments arrive all the time, and your regulatory team needs to know what each one asks for.
How regulatory submission drafting works
Enterprise h2oGPTe indexes the documents you approve in your environment and drafts from them with citations, so your writers start from a sourced draft instead of a blank page.
Step 1: assemble the package
You load the approved sources for a submission into a private collection: study reports, safety summaries, prior submissions, labels and your submission template.
Step 2: check for gaps and consistency
H2O AI Super Agent checks the package against your table of contents, lists the sections with no source yet, and flags values that differ across documents.
Step 3: draft a section
Your medical writer asks for a first draft of a section, such as a cumulative exposure summary. Enterprise h2oGPTe uses retrieval-augmented generation over your approved sources and writes in your template, with a reference to the passage behind each statement.
Step 4: pull tables into structured data
H2O Document AI extractors can pull tables and fields from source reports into structured output that matches a schema you define, for your writer to check against the source.
Step 5: review health authority correspondence
Your team loads a health authority letter or guidance update and asks what it requires. The assistant lists each request with the passage it came from and the documents in your collection that it touches.
Step 6: review and sign
Your medical writers and regulatory staff edit every section. Medical content goes to your safety physicians, and the qualified person your process names reviews and signs. The assistant does not submit anything to a health authority.
Drafts your reviewers can check
Every retrieval-based answer carries references to its sources. This grounded generation lets your reviewers open the source passage and catch errors before a draft moves forward.
Proof
H2O can be used to draft cited sections of safety reports and submissions, check packages for gaps, and review regulatory text, with a person signing every document. H2O has no named life sciences customer today, so this page describes the pattern, not a deployment.