AI that gets biopharmaoperations work done.
Sofie brings your knowledge, the world’s regulators, specialized AI agents and your experts’ judgment into one system of work, for quality, regulatory, tech transfer, manufacturing and supply teams.
Speaking
SOFIE
LB-204 Process Transfer Plan
Source: SofieWorkspaceARShare6. Intermediate Hold Times
6.2 Receiving-site hold limits
Intermediates shall be held within the limits established in the sending-site hold-time study. Clarified harvest (HT-3) shall not exceed 96 hours at 2–8 °C.
6.3 Excursion handling
Sofie Voice, in split screen. Talk it through; watch the work get built beside you.
About Sofie VoiceBuilt across the biopharma ecosystem
- CDMOs
- Emerging biotech
- Commercial biopharma
- Suppliers to industry
- Life sciences technology
- Engineering & consulting
Why Sofie
Theknowledgebehindeverymedicineisspreadacrosspeople,documents,systemsandstandards.Sofieconnectsittoeveryworkflow,decisionanddeliverable,andkeepseveryconclusiontiedtoitsevidence.
The platform
One platform, from context to decision to deliverable.
Everything your team needs to move complex work forward, with Sofie working alongside them in every surface.
Every program, with its context attached
Files, conversations, deliverables, meetings and collaborators organized around each program, site or client, synced from SharePoint, OneDrive and Google Drive.
Explore WorkspacesDocuments that survive the trip to Word
Sofie drafts, redlines and cites inside a Word-faithful editor your team co-edits in real time, with tracked changes, comments and templates.
Explore CoDraftAnalysis you can see and edit
Batch data, trending and comparisons in a real spreadsheet: formulas, pivots and charts, with Sofie filling columns and explaining what changed.
Explore CoSheetFrom conversation to client-ready
Decks, dashboards, pages and live trackers that stay connected to the data and chat that produced them. Export to PowerPoint, PDF or video.
Explore SurfacesAgents that hand work to each other
Coordinate specialized agents across research, comparison and drafting, with the review points and approvals your experts define.
Explore OrchestrationsWorking sessions that write themselves up
Live transcripts with speakers, notes shaped to the meeting type, and decisions and actions that flow into the work.
Explore CoMeeting
Workspaces / Tech Transfer
LB-204 Tech Transfer
Files
Members
Syncing from SharePoint · 231 files
Recent files
Name · ModifiedThe 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
New · Regulatory Intelligence
The entire regulatory world.
One question away.
Official regulations, guidance, inspections, recalls, shortages and approvals from nine authorities, refreshed every day. Every answer traces to its source, page and date.
- regulatory records
- 0+
- official documents
- 0+
- live source connectors
- 0
- authorities, from FDA to PMDA
- 0
regulatory records
official documents
live source connectors
authorities, from FDA to PMDA
FDA drug establishment registrations
10,477 sites. 83 countries.
10,477 FDA-registered drug sites · 83 countries
Ready on day one
Over a hundred workflows and templates. Built by operators.
Start from prebuilt biopharma workflows for tech transfer, CQV, quality records, supply chain and regulatory work, or configure your own around the way your organization operates.
Workflows
Tech Transfer
Charters, transfer plans and comparability
Workflows
Process Development
Development plans, reports and characterization
Workflows
Analytical Development
Method plans, transfers and validation
Workflows
CQV
Qualification, validation and process performance
Workflows
Quality Records
Deviations, CAPAs and change control
Workflows
Regulatory & CMC
Submissions, gap assessments and responses
Workflows
Supply Chain
Supplier qualification, risk and readiness
Workflows
Business Development
Proposals, feasibility and statements of work
Workflows
Business Operations
Costing, readouts and program reporting
Workflows
Tech Transfer
Charters, transfer plans and comparability
Workflows
Tech Transfer
Charters, transfer plans and comparability
Workflows
Process Development
Development plans, reports and characterization
Workflows
Analytical Development
Method plans, transfers and validation
Workflows
CQV
Qualification, validation and process performance
Workflows
Quality Records
Deviations, CAPAs and change control
Workflows
Regulatory & CMC
Submissions, gap assessments and responses
Workflows
Supply Chain
Supplier qualification, risk and readiness
Workflows
Business Development
Proposals, feasibility and statements of work
Workflows
Business Operations
Costing, readouts and program reporting
Workflows
Tech Transfer
Charters, transfer plans and comparability
Templates
Tech Transfer & Development
Plans, protocols and summary reports
Templates
Validation & CQV
Protocols, reports and traceability
Templates
Quality Records
Investigations, CAPAs and reviews
Templates
Regulatory
Submission sections and correspondence
Templates
Business & Commercial
Proposals, agreements and readouts
Templates
Meeting summaries
Notes shaped to the meeting you held
Templates
Tech Transfer & Development
Plans, protocols and summary reports
Templates
Validation & CQV
Protocols, reports and traceability
Templates
Quality Records
Investigations, CAPAs and reviews
Templates
Regulatory
Submission sections and correspondence
Templates
Tech Transfer & Development
Plans, protocols and summary reports
Templates
Validation & CQV
Protocols, reports and traceability
Templates
Quality Records
Investigations, CAPAs and reviews
Templates
Regulatory
Submission sections and correspondence
Templates
Business & Commercial
Proposals, agreements and readouts
Templates
Meeting summaries
Notes shaped to the meeting you held
Templates
Tech Transfer & Development
Plans, protocols and summary reports
Templates
Validation & CQV
Protocols, reports and traceability
Templates
Quality Records
Investigations, CAPAs and reviews
Templates
Regulatory
Submission sections and correspondence
Sequences & Memory
Work that runs on its own. Context that carries forward.
Sequences handle the recurring and the reactive: a brief every weekday morning, a supplier review when FDA posts a new Form 483, follow-ups when a meeting ends. Memory keeps your standards, preferences and past decisions at hand, and each person can review, edit or delete what it keeps.
Your sequences
Supplier 483 alerts
Regulatory change published
Weekday quality brief
Every weekday 7:00
Meeting follow-ups
Transcript ready
USP revision alerts
Regulatory change published
When
FDA posts a Form 483 for a supplier on your list
Approved suppliers · 57 sites
Then
Run Supplier Risk orchestration
Updates the Supplier risk Surface
Then
Notice to Quality, drafted by the run
Needs approval before sending
Notify if
Observations mention sterility or aseptic processing
Checked after each run
Run log · today
Checked daily
Proven outcomes
- average time savings per workflow
- 60–80%
- workflows improved across operations in the first 30 days
- 10–15
- of hours returned to teams each month
- Hundreds
“With Sofie, our team members have completed in minutes work that would have taken hours or days. That's not a one-time thing. We've seen it across workflows, across functions. I'm a believer.”
Trust & security
Your data, protected by design.
Every customer runs in its own isolated AWS environment with an encrypted database, enterprise sign-in and access you control. Your data never trains a model.
More about securityAn isolated deployment for every customer
Your own AWS environment for the application and database: a dedicated VPC, private subnets and an encrypted database.
Your data never trains a model
Customer content is used to do your work, and nothing else.
Enterprise sign-in
SAML SSO with Okta, Entra ID, Google Workspace and more, passkey MFA and configurable idle timeouts.
Human approval where it matters
Sending, sharing and unattended work pause for approval by default.
Evidence for every conclusion
Answers carry page-level citations, and Sofie is built to flag missing evidence rather than fill the gap.
Traceable history
Security events, access reviews and change history your administrators can review.
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.