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
From the regulators to your desk. One system of work.
01The regulatory world
Official regulations, guidance, inspections and approvals from FDA, EMA, PMDA, Health Canada, TGA and the major standards bodies, checked on regular schedules and cited to the source. Coverage keeps growing.
Explore02Your knowledge
SOPs, batch records, protocols, specifications and prior work: synced from SharePoint, OneDrive and Google Drive into Workspaces, searchable to the page.
Explore03Institutional memory
Your role, products, preferences and past decisions, kept as memory linked to its evidence, so work starts where it left off.
Explore04Specialized agents
Orchestrations coordinate agents across research, comparison and drafting, pausing at the review points your experts define.
Explore05Review-ready work
CoDrafts, CoSheets and Surfaces your team edits together: the deliverable, with its sources attached.
Explore06Your Integrations
Microsoft 365, Google Workspace, Salesforce and Snowflake connect the work to your systems. Need to bring in your QMS, LIMS, ERP or a specialist tool? Our team builds the connection around your data and the way you work.
Explore integrations
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 over a hundred prebuilt 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 regulatory authorities, 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.
01
Context
Workspaces, memory and synced files give Sofie your programs, standards and history before the first question is asked.
02
Research
Sofie reads across your files, nine regulatory authorities and the web, and cites every claim.
03
Agents
Orchestrations and Sequences carry multi-step work forward, pausing at the review points your experts define.
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. Prompts and skills can be shared with colleagues or the whole organization.
Guest access for partners
Invite clients, suppliers and receiving sites into a single Surface with view or participate access. Guests see only what their invitation allows.
6. Cleaning and hold times
A. Ruiz
Can the receiving site confirm the 72 h hold?
J. Okafor Process
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. Bring together files, conversations, customer records and warehouse data. For the systems specific to your operation, our team builds integrations around the data and actions your work needs.
Microsoft 365
OutlookOneDriveSharePointCalendar
Google Workspace
GmailDriveCalendar
Salesforce
CRM
Snowflake
Data warehouse
Built around your operation
Your systems. Our next connection.
Your QMS, LIMS, ERP, MES and specialist tools hold context worth putting to work. We work with your team to connect the records, readings and actions that matter, so Sofie fits the systems you already rely on. You can also start with documents and exports you sync or upload.
Talk through your integrationsModels
Sixteen models. Auto picks the right one.
Auto routes each request to a fast, balanced or deep model, with life-sciences safety minimums for consequential work. Choose a specific model whenever you prefer.
About Research & ChatAnthropic
- 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
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.