Function · Regulatory Affairs
CTD dossiers drafted from your records, reviewed before you file.
SyncIQ drafts Module 1, 2 and 3 and checks each section against ICH and agency guidance before your team reviews it.
A dossier is filed in many markets and maintained for years, as labels and guidance change.
Capabilities
What SyncIQ does.
CTD Module 3 and the Quality Overall Summary
Drafted to your template from BMRs, CoAs and stability data. Every value links to its source page.
Regulatory AtlasSee Regulatory AtlasPre-submission review against refuse-to-receive criteria
Plus checks against guidance, your past queries and SOP checklists. Findings graded Critical, Major or Minor.
Regulatory AtlasSee Regulatory AtlasNext-market dossiers in eCTD or ACTD
Module 1 or Part I content for the next authority, built from your reference dossier, gaps flagged.
Regulatory AtlasSee Regulatory AtlasPost-approval variations and renewals
Type IA, IB and II variations, renewals and annual reports, drafted from the change record that triggered them.
Regulatory AtlasSee Regulatory AtlasHealth authority query responses
Drafted from your dossier and the correspondence your team has already sent.
Regulatory AtlasSee Regulatory AtlasReference label changes, checked against your filings
Reference labels tracked across your markets, with each change flagged against your filed content.
Label WatchSee Label WatchGuidance answers with the citation attached
ICH, FDA and EMA guidance and 21 CFR, plus approval pathways and precedent from the public record.
RegIntelSee RegIntel
The applications
Four applications, one for each job.
Regulatory Atlas
Module 1, 2 and 3, authored and reviewed
Module 3 and the QOS, next-market filings, variations and query responses, in one workspace.
See Regulatory Atlas
Label Watch
Reference label changes, tracked and compared
Watches reference and RLD labels in every market you've filed in and flags which of your sections to update.
See Label Watch
RegIntel
Cited answers on guidance, pathways and precedent
Regulatory intelligence for guidance questions, approval pathways, timelines and precedent. Each answer cites the passage it came from.
See RegIntel
Vault
Source files classified, submissions assembled
Classifies source files as they come in and records which version of each document went into each sequence.
See Vault
The flagship
Regulatory Atlas authors and reviews the dossier.
Every value in the QOS links to its Module 3 section, and inconsistencies between the two are flagged.
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
Results on Module 3 and QOS drafts.
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's covered, and the standards behind it.
Built in eCTD or ACTD structure, to the requirements of the authority you file with.
What SyncIQ produces
- CTD Module 3, from batch records, CoAs and stability data
- The QOS and Module 2 summaries, each checked against its source
- Module 1 regional forms for the authorities you file with
- Variations, renewals and annual reports
- A new market's filing, from your reference dossier
- Responses to health authority queries
ANDA, NDA, BLA and IND. Publishing stays in the tools you have already validated.
ACTD
The ASEAN Common Technical Dossier arranges a submission in four parts: administrative data and product information, quality, nonclinical and clinical. Part I holds administrative documents, such as application forms and labeling, that each authority sets.
Post-approval changes
One change, two classifications: prior approval supplement, CBE‑30, CBE‑0 or annual report in the US; Type IA, IB or II variation in the EU, under guidelines applying since January 15, 2026.
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Start where it hurts.
We'll run Regulatory Atlas live on a section of your dossier.
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