Regulatory Affairs
Submissions authored and reviewed, from your own records.
Dossier authoring, label surveillance and guidance answers are three different jobs. So they are three different applications, plus one holding the documents underneath.
The applications for regulatory affairs.
Each one is a family of related work rather than a single workflow, built with the specialists who do it.
Regulatory Atlas
Module 1, 2 and 3, authored and reviewed
Your CMC data already exists, in batch records, CoAs and stability reports nobody wrote for a machine to read. Atlas reads them anyway and drafts the dossier to your template, then reviews its own draft before your team opens it.
See Regulatory Atlas →
Label Watch
Reference label changes, tracked and compared
A reference label changed four months ago. Nobody told you. Label Watch tracks reference and RLD labels across your markets, compares what moved, and flags it against your own filed content.
See Label Watch →
RegIntel
Cited answers on guidance, pathways and precedent
“What does the guideline actually say?” Two hours later you're still reading. RegIntel answers from ICH, FDA and EMA guidance with the citation attached, plus approval pathways, timelines and precedent from the public record.
See RegIntel →
Vault
Source files classified, submissions assembled
Fourteen thousand files in the data room, and nobody is certain which version went into the last submission. Documents are classified and filed as they arrive, the submission assembles across versions and sequences, and every authored value knows the page it came from.
See Vault →
What arrives.
The documents this function is judged on, authored from your own records and reviewed before your team opens them.
- Module 3 quality content, written from batch records, CoAs and stability data
- Module 2 summaries for quality, nonclinical and clinical, each checked against the module underneath it
- Module 1 regional forms per market, eCTD or ACTD
- Variations, renewals and annual reports, drafted off the change record
- A new market's dossier expanded from one already approved
- Every value carrying a link to the page it came from
NDA, ANDA, BLA, IND. Publishing through tools you have already validated.
Start where it hurts.
We'll run it live on a section of your own work.
Request a demoYour data stays in your environment. Customer data never trains foundation models.