Skip to contentSofie Regulatory Intelligence: nine regulators, one place, updated every day.

The platform

One system of work,from context toreview-ready.

Sofie brings your documents, the world’s regulators, specialized agents and your experts’ judgment into one platform. Thirteen connected products, built for the quality, regulatory, tech transfer, manufacturing and supply teams behind every medicine.

The Sofie stack

Five layers. One system of work.

  1. 01Your knowledge

    SOPs, batch records, protocols, specifications and prior work: synced from SharePoint, OneDrive and Google Drive into Workspaces, searchable to the page.

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  2. 02The regulatory world

    Nine authorities and 36 live sources, from 21 CFR to Form 483s, EudraGMDP and PMDA review reports. Refreshed daily, every claim cited.

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  3. 03Institutional memory

    Your role, products, preferences and past decisions, kept as governed memory, so work starts where it left off.

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  4. 04Specialized agents

    Orchestrations coordinate agents across research, comparison and drafting, pausing at the review points your experts define.

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  5. 05Review-ready work

    CoDrafts, CoSheets and Surfaces your team edits together: the deliverable, with its sources attached.

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01 · Work together

Where people and Sofie do the work, side by side.

Documents, spreadsheets, Surfaces and meetings your team works on together in real time, with Sofie drafting, analyzing and citing in the same place.

02 · Automate

Agents, workflows and schedules that carry work forward.

Orchestrations coordinate specialized agents, the library gives you 116 workflows to start from, templates set the format, and Sequences run the work on a schedule or trigger.

03 · Intelligence

What Sofie knows, remembers and hears.

Nine regulators, your institutional memory, hands-free voice and deep research across every source, with each answer tied to its evidence.

How work moves

From a question to a deliverable you can sign.

Every product plays a part in the same path. Context goes in, evidence is gathered, agents do the multi-step work, and people review what comes out.

  1. 01

    Context

    Workspaces, memory and synced files give Sofie your programs, standards and history before the first question is asked.

  2. 02

    Research

    Sofie reads across your files, nine regulatory authorities and the web, up to 24 sources per answer, and cites every claim.

  3. 03

    Agents

    Orchestrations and Sequences carry multi-step work forward, pausing at the review points your experts define.

  4. 04

    Review-ready deliverable

    The output lands as a CoDraft, CoSheet, filled template or Surface your team can edit, check and approve, with sources attached.

Collaboration

Built for teams, and the partners they work with.

  • Real-time co-editing

    CoDrafts, CoSheets and the orchestration builder show presence avatars and live cursors, with Sofie working in the same document.

  • Comments and one inbox

    Comment on documents, workspace files and spreadsheet cells. Mentions and replies arrive in a single notification inbox.

  • Groups with their own setup

    Teams get their own AI instructions, brand logo and colors, integration credentials and usage alerts, plus shared prompt and skill libraries.

  • Guest access for partners

    Invite clients, suppliers and receiving sites into a single Surface with the role you choose. Guests see only what their invitation allows.

Process Transfer Plan · LB-204
ARMKNB
3 editing now

6. Cleaning and hold times

M. Kline

A. Ruiz

Can the receiving site confirm the 72 h hold?

Northwind QA Guest

Confirmed in HTS-014, section 5.3.

Integrations

Connected to the tools your teams already use.

Connect accounts for the whole organization or per group. Sofie also works across your systems of record: ERP, eDMS, MES, QMS and PMIS.

  • Microsoft 365

    OutlookOneDriveSharePointCalendar

  • Google Workspace

    GmailDriveCalendar

  • Salesforce

    CRM

  • Monday.com

    Work management

  • Linear

    Issues and comments

  • Mercury

    Banking

  • Ramp

    Spend

  • FullEnrich

    Contact enrichment

Models

Sixteen models. Auto picks the right one.

Auto routes each request to a fast, balanced or deep model, with life-sciences safety minimums on every answer. Choose a specific model whenever you prefer.

About Research & Chat
  • Anthropic

    • Claude Fable 5.1
    • Claude Opus 5.5
    • Claude Sonnet 5.5
    • Claude Haiku 4.5
  • OpenAI

    • GPT-6 Astra
    • GPT-6.1 Sol
    • GPT-5.6 Terra
    • GPT-6 Luna
  • Google

    • Gemini 3.1 Pro
    • Gemini 3.8 Flash
    • Gemini 3.5 Flash Lite
  • Meta

    • Muse Spark 1.2
  • xAI

    • Grok 4.6
  • Moonshot AI

    • Kimi K2.6
  • Z.ai

    • GLM 5.3
    • GLM 5.3 Flash

00:00:00:00

Product film · Workspaces to deliverables in three minutes · In production

A tour of Sofie

3:00 target

Start with one workflow.
Measure it. Then expand.

In a working session we choose a priority workflow, define your standards and review points, and agree how to measure speed, quality and capacity. Then you evaluate Sofie's work before deciding whether to expand.