Function · Regulatory Affairs
Submissions authored and reviewed, from your own records.
From the first Module 3 draft to the last post-approval variation: SyncIQ authors regulatory content from your own source data, reviews it against the guideline before your team opens it, and keeps every claim traceable to its origin.
Dossier authoring, label surveillance and guidance answers are three different jobs. So they are three different applications, plus one holding the documents underneath.
What arrives
Every place a submission slows down or draws a question.
Module 3 arrives written from your batch records.
Module 3 sections and Module 2 summaries drafted from BMRs, CoAs and stability data. Every value carries its page reference.
Regulatory AtlasSee Regulatory AtlasThe draft is checked before your review cycle starts.
Checked against current guidelines, refuse-to-receive criteria, your prior queries and your own SOP checklists. Findings come back severity-graded.
Regulatory AtlasSee Regulatory AtlasThe next market's dossier arrives mapped from the one you filed.
Country-specific Module 1 and Part 1 content generated and mapped, gaps flagged, in eCTD and ACTD. Expansion becomes a review of what changed.
Regulatory AtlasSee Regulatory AtlasEvery variation is drafted before the date moves.
Post-approval variations authored and tracked across markets, with full version history. Nothing depends on who remembers the renewal calendar.
Regulatory AtlasSee Regulatory AtlasThe query response arrives drafted from your own dossier.
Drafted from your source data and prior correspondence. Every answer your team has given is in front of whoever drafts today.
Regulatory AtlasSee Regulatory AtlasA label that moved is flagged against what you filed.
Label versions monitored across every market you have filed in, checked against source and prior versions while the difference is still an edit.
Label WatchSee Label WatchGuideline answers arrive with the citation attached.
FDA and ICH questions answered from the guidance text, alongside an approval database and pathway research. Strategy argued from the source.
RegIntelSee RegIntel
The applications
Four applications, one evidence base.
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
The product
Delivered by Regulatory Atlas.
Regulatory Atlas is the authoring and review workspace the other three read from, on one knowledge base, one audit trail and one security model. So the source your team approved in Module 3 is the source the label check cites two years later.
The draft
The source
- Storage condition: 25°C ± 2°C / 60% RH ± 5%
- 36 months · no significant change observed
- Trend analysis: all CQAs within specification
Click a citation and the originating record opens in split-screen. Field-level lineage, on every value.
Proof points
Where the time actually goes now.
Measured across pilot deployments on Module 3 and Module 2 work for FDA and EU submissions.
- 80%
- faster to first draft
- 70–90%
- first-draft completeness
Measured in active deployments. Results vary by submission type.
Coverage
What you file today, and where you file next.
SyncIQ covers the administrative and regional content (Module 1), the summaries (Module 2, QOS and clinical), the quality dossier (Module 3) and clinical documentation (Module 5) across ANDA, NDA and BLA submissions, in eCTD and ACTD.
What lands on your desk
- 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.
Working on something in regulatory that you don't see here? Tell us the work that's slowing you down →
Start where it hurts.
We'll run it live on a section from your own dossier. Pick the section that matters most to your team.
Request a demoYour data stays in your environment. Customer data never trains foundation models.