From your stability data, BMRs, COAs, and analytical records to a working draft across 3.2.S, 3.2.P, and Module 2.3 QOS. Your team reviews and refines from a structured first draft.
The Problem
Dossiers must comply with stringent ICH Q-series guidelines and the specific requirements of every major health authority. Every section must be complete, consistent, and traceable to its source data, across two manual, high-stakes workflows with no margin for error.
Thousands of pages of Manufacturing, QC, and Clinical data, compiled into structured regulatory narratives and written from scratch in Word by senior regulatory experts.
Multiple rounds of internal checking to catch compliance issues and inconsistencies across source files and modules before submission.
A regulatory query, whether a Complete Response Letter, a Day 120 question, or a refuse-to-file decision, delays approval and the launch revenue that depends on it.
Capabilities
Regulatory professionals stay fully in control: reviewing, refining, and approving every section. SyncIQ accelerates the work. Your team owns the judgment.
01 · Fast
SyncIQ reads your BMRs, COAs, stability reports, and analytical records to generate structured Module 2 and Module 3 content. Authors walk into a working draft within days, with every value and statement already tied to its source. The platform covers ANDA, NDA, BLA, and IND submissions across the full CMC scope.
02 · TRACEABLE
Every CMC value, statement, and data point in the generated draft is source-linked within the document. Click a reference indicator to open a split-screen view showing the originating BMR, stability report, or analytical record.
Every assay result, impurity threshold, and stability conclusion can be verified against the underlying record in seconds.
03 · CONSISTENT
SyncIQ keeps Module 2 QOS and Module 3 in sync automatically. Every value, claim, and terminology choice in the QOS summary is linked to its corresponding Module 3 section, so a change in one carries through to the other.
Cross-module inconsistencies are flagged before any human review cycle begins. There is no manual reconciliation pass, no version drift, and no misalignment that slips through to the reviewer.
04 · COMPLIANT
Every draft section is checked for completeness, consistency, and scientific accuracy against current ICH Q-series guidelines, agency-specific guidance (FDA, EMA, MHRA, PMDA, and others), and pharmacopoeial requirements.
Issues are surfaced with severity tags and proposed corrections your team can accept or reject, before any human review cycle begins.
What pilots are seeing
Measured across active pilots preparing Module 3 and Module 2 QOS for FDA and EU submissions across multiple pharmaceutical organisations.
Results may vary by submission type and source-document quality.
How it works
Authoring a dossier section takes more than a single prompt. SyncIQ works through extraction, planning, drafting, critique, rewriting, and refinement as specialized agents, covering every section from start to finish.
SyncIQ ingests hundreds of source documents in a single pass, covering stability studies, BMRs, COAs, analytical records, and validation protocols. The Data Research Agent classifies each document, extracts the parameters relevant to the target CTD section, and surfaces them in structured form, so authoring begins with the right data already on the page.
Before drafting begins, SyncIQ generates a section blueprint covering what the CTD section must contain, which ICH Q-series and agency-specific guidance applies, what data elements are required, and how prior submission precedent has shaped the format. Every subsequent authoring step builds from this foundation.
The Authoring Agent generates section content aligned to module-specific format expectations, with every value source-linked at the field level. Tables, narratives, methods, and acceptance criteria are all produced in CTD-appropriate structure. Module 2 summaries and Module 3 content estay aligned throughout, without a manual reconciliation step
The Compliance Review Agent applies the same checks a senior regulatory reviewer would, covering ICH Q-series, agency-specific guidance, and Pharmacopoeial requirements. It flags weak claims, missing cross-references, inconsistent values across modules, and sections where supporting evidence is thin. Every finding is tagged Critical, Major, or Minor and surfaced before a human reviewer opens the document.
Each finding from the Critique step is addressed individually, with targeted edits applied to the specific section, claim, or value that needs correction. Source linkage is preserved through every revision making the reauthored draft materially closer to submission-ready quality than any first-pass AI output.
Regulatory authors can make targeted natural-language edits through the AI Refine panel, instructing the system to convert content into tables, simplify language, or tighten section descriptions, all within CTD expectations. Version control, source linkage, and audit trail are preserved across every edit, and nothing exits the governed environment without a complete log of changes.
Across the lifecycle
Pre-approval through post-market surveillance. SyncIQ is built to handle every regulatory document and workflow your team owns, on a single connected platform.
Request a 30-minute walkthrough built around a section from your own dossier work. Pick the section that matters most to your team, and we'll run it live.