Request a demo

The Agent OS forLife Sciences.

Transform every function where being wrong isn't an option. A gap in Module 3 comes back as a deficiency letter. A formulary change you missed comes back as a rebate you didn't owe. Each function, same problem.

Other industries

The same OS, wherever being wrong isn't an option.

Describe regulated document work in any industry. The OS stands up the application: the data model, the workflows, the agents, the screens. Audit trail, version control and role-based access come with it.

Experience

the journey your team works in

Workflow

agentic and deterministic steps

Agents

the right one for each job

Data & knowledge

your systems, your history

One OS underneath

RegPulse runs on it today, checking every circular against the policy set at banks, insurers and asset managers.

See the Agent OS Financial services →
5of top 20
Indian pharmaceutical companies, using SyncIQ on their own submissions
500+
guidelines ingested. ICH, FDA, EMA and 21 CFR, kept current
20,000+
automated compliance checks run against draft content
100%
of authored values traceable to source. Every agent run auditable.

As of July 2026.

AI writes the first draft. You make the last call.

Ask what held up the last deadline. Nobody says the science.

Life sciences still runs on databases that had AI added later, so a person does the work and the AI helps at the edges. These applications run the other way round.

The agent reads the sources and writes the draft. Your team reviews it, in every function.

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.

NDA, ANDA, BLA, IND. Publishing through tools you have already validated.

Everything in regulatory affairs

What arrives

  • 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
Request a demoTell us the work that’s slowing you down

How your organization works:Pharma & genericsBiotechCROsCDMOsMedTech

Featured application · Regulatory Atlas

The whole dossier, not one section of it.

  1. It reads what you already have.

    Batch records, CoAs and stability reports, scanned and handwritten included. Nobody wrote them for a machine to read. Atlas reads them anyway.

  2. It drafts to your template.

    Module 3 from your own records, Module 2 written from the module it summarizes, Module 1 to each authority's forms. eCTD or ACTD.

  3. It reviews its own draft first.

    Against the guideline, refuse-to-receive criteria and your own SOP checklists, before your team opens it. Findings come back graded by severity.

NDA, ANDA, BLA, IND. Publishing through the tools you've already validated.

See Regulatory Atlas
80%
faster to first draft
70–90%
first-draft completeness

Measured in active deployments. Results vary by submission type.

Built for the way your organization files.

One OS underneath all of it.

Describe the work and Agent OS stands the application up: the data model, the workflows, the agents, the screens. Audit trail, version control and role-based access come with it. Not bolted on after the pilot.

  1. Regulatory AtlasRegulatory Affairs
  2. Clinical ScribeClinical Development
  3. Formulary VerificationMarket Access
  4. Investigation DeskQuality & Manufacturing
  5. Aggregate SafetyPharmacovigilance
  6. MedInfo DeskMedical Affairs
  7. Promo CheckCommercial
  8. Evidence DeskR&D
  9. Your journeyweeks, not quarters

Agent OS · one platform

Running today

  • One knowledge base

    Your templates, SOP checklists and past submissions, shared by every application.

  • One audit trail

    Every run logged. Every authored value traceable to the source page it came from.

  • One security review

    Pass it once. Every function you add afterwards inherits it.

See the Agent OS Bring us a journey we haven’t built

It already speaks your systems, the public record, and your own history.

  • Your systems

    Document and quality management. Lab and clinical data. Safety databases. RIM and publishing. Data rooms and file shares. Credentials brokered, never sitting inside a workflow.

    • SharePoint · live today
    • MCP-native
    • Your connector · about a week

  • Your records, however they arrive

    Structured exports, scanned PDFs, handwritten batch records. The documents that carry the truth on a manufacturing floor were never designed to be machine-readable, and most tools quietly need them to be.

  • The public record

    ICH, FDA and EMA guidance, 21 CFR, and the CTD, eCTD and ACTD specifications including regional Module 1 per market. Alongside the databases your team searches by hand today, kept current so a change reaches you rather than a newsletter.

    • PubMed and MEDLINE
    • ClinicalTrials.gov
    • International trial registries
    • Drugs@FDA
    • DailyMed and reference labels
    • Orange Book and Purple Book
    • FAERS
    • Warning letters and inspection findings

  • Your own history

    Your templates. Your SOP checklists. Your past submissions. Every question the agency has already asked you. No vendor can ship you this, and it's the part that compounds.

Your IT team gets answers, not hand-waving.

  • 01

    Deployment

    SaaS or private cloud/VPC, data residency in the US, EU or India, bring-your-own-key.

  • 02

    Security

    Enterprise SSO and RBAC, AES-256 in transit and at rest, customer data never used to train foundation models.

  • 03

    Governance

    21 CFR Part 11-aware, full audit trail, version history, source traceability through revisions.

  • 04

    Integration

    MCP-native, SharePoint live today, standard connectors in about a week.

Security, compliance and deployment in full Request the security summary

Nothing goes out that your team hasn't approved.

SyncIQ drafts, checks and flags. It doesn't decide.

SyncIQ drafts, checks and flags. It doesn't decide. Every output arrives with its sources attached and its open questions marked. The person accountable for the filing is still the person who signs it. What disappears is transcription, formatting and cross-checking. What gets more valuable is judgment.

Insights

From the team building it.

View all insights

Start where it hurts.

Pick the function slowing your team down today. We'll run it live on a section of your own work.

Request a demo

Your data stays in your environment. Customer data never trains foundation models.