The friction isn't in the formulas.

It's in the transfer of knowledge.

The friction isn't in the formulas.

It's in the transfer of knowledge.

The friction isn't in the formulas.

It's in the transfer of knowledge.

The friction isn't in the formulas. It's in the transfer of knowledge.

Purpose-built AI to move every day work forward.

Meet Sofie

AI designed to earn its place on your team by adapting to the way your team works.

Built to enable, not constrain

Sofie is built on a multi-model platform — adapting to your expertise, your standards, and your pace. What begins as individual value scales naturally across the organization.

Built to enable, not constrain

Sofie is built on a multi-model platform — adapting to your expertise, your standards, and your pace. What begins as individual value scales naturally across the organization.

Collaborate seamlessly

Work alongside Sofie and your teammates across documents, transcripts, orchestrations, and emails so work moves forward without losing traction.

Collaborate seamlessly

Work alongside Sofie and your teammates across documents, transcripts, orchestrations, and emails so work moves forward without losing traction.

Context that compounds

Your work is cumulative. Every phase builds on the last. With memory, Sofie understands your standards, preferences, and organizational context, compounding over time so outputs grow more precise and more aligned with how you work.

Context that compounds

Your work is cumulative. Every phase builds on the last. With memory, Sofie understands your standards, preferences, and organizational context, compounding over time so outputs grow more precise and more aligned with how you work.

One platform to streamline complex workflows, enhance accuracy, and scale your team's capabilities across the full scope of operations.

Agentic orchestrations

Built on a proprietary agentic framework designed for biopharma, orchestrations automate any workflow — from GxP-critical processes to cross-functional operations beyond. Start from a library of prebuilt, biopharma-specific orchestrations or build your own, even by describing what you need out loud with voice mode. Run them whenever you want, you define the scope and checkpoints, the agents handle the rest.

Workspaces

Your work spans projects, accounts, and teams — each carrying its own complexity, history, and context. Most tools store that context. Workspaces activate it. Every file, conversation, and draft becomes the foundation Sofie draws on to work faster, think deeper, and execute with precision that compounds over time.

Chat, context, prompts

Every AI platform has chat. What sets Sofie apart is context. Pull your workspace files, meeting notes, and templates directly into the conversation and handle technical tasks from document comparison and drafting to data extraction and analysis without switching tabs or losing flow. Save prompts for your routine work and rerun them any time with precision, every time.

Templates

Consistency and conformity are the foundation of your work. With templates, you ensure the same quality output from Sofie every single time. Sofie fills each instance with the specific data and context you provide, in the exact way you want it presented, whether it's an SOP, batch record, deviation report, or regulatory submission.

Outputs in minutes

Sofie delivers the precision your work demands, without the overhead it used to take.

CoDraft

Turn analysis into deliverable. CoDraft draws from your documents and expertise to produce technical reports, SOPs, and client deliverables — ready for review and export.

CoDraft

Turn analysis into deliverable. CoDraft draws from your documents and expertise to produce technical reports, SOPs, and client deliverables — ready for review and export.

CoSheets

Turns complex data into clear analysis. CoSheets handles formulas, visualization, and pattern detection, then structures results for batch review, trend reporting, and comparative analysis.

CoSheets

Turns complex data into clear analysis. CoSheets handles formulas, visualization, and pattern detection, then structures results for batch review, trend reporting, and comparative analysis.

CoMeeting

Captures every conversation, summarized and searchable. CoMeeting preserves context as transcripts, structured summaries, and action items so decisions carry forward across teams and handoffs.

CoMeeting

Captures every conversation, summarized and searchable. CoMeeting preserves context as transcripts, structured summaries, and action items so decisions carry forward across teams and handoffs.

Your intelligence, finally connected

Your systems hold years of operational intelligence that's never been connected — Sofie brings it together.

Your QMS, ERP, LIMS, regulatory databases, SOPs, and batch records already contain the intelligence your team needs. Sofie connects across all of them so that intelligence is available in every conversation, every workflow, and every decision, without asking your team to change how they work.

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Regulatory Intelligence

  • Web Sources

Data Connections

  • Google
  • ERP
  • eDMS
  • Salesforce
  • MES
  • Microsoft
  • QMS
  • PMIS

Your Knowledge

  • Internal Workflows
  • Proposals
  • SOPs and Protocols
  • Batch Records
  • Process Flows
  • Policies
  • Templates
  • Specifications
  • File Uploads
  • Regulatory Submissions
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Regulatory Intelligence

  • Web Sources

Data Connections

  • Google
  • ERP
  • eDMS
  • Salesforce
  • MES
  • Microsoft
  • QMS
  • PMIS

Your Knowledge

  • Internal Workflows
  • Proposals
  • SOPs and Protocols
  • Batch Records
  • Process Flows
  • Policies
  • Templates
  • Specifications
  • File Uploads
  • Regulatory Submissions
button

Regulatory Intelligence

  • Web Sources

Data Connections

  • Google
  • ERP
  • eDMS
  • Salesforce
  • MES
  • Microsoft
  • QMS
  • PMIS

Your Knowledge

  • Internal Workflows
  • Proposals
  • SOPs and Protocols
  • Batch Records
  • Process Flows
  • Policies
  • Templates
  • Specifications
  • File Uploads
  • Regulatory Submissions
button

Regulatory Intelligence

  • Web Sources

Data Connections

  • Google
  • ERP
  • eDMS
  • Salesforce
  • MES
  • Microsoft
  • QMS
  • PMIS

Your Knowledge

  • Internal Workflows
  • Proposals
  • SOPs and Protocols
  • Batch Records
  • Process Flows
  • Policies
  • Templates
  • Specifications
  • File Uploads
  • Regulatory Submissions

Security and compliance

Built to the standard your IT and compliance teams expect.

TransferAI is built for the security standards biopharma demands. Every client runs in its own isolated environment — fully containerized, never shared. Your data stays within your deployment. No AI model is ever trained on your information. Built on AWS infrastructure trusted across regulated life sciences, with end-to-end encryption, complete audit traceability, and alignment with industry guidelines.

Impact

From time saved to productivity gains, these
results show what's possible when biopharma operations are reimagined.

  • "What used to take me half a day searching through guidance's and cross-referencing documents, Sofie handled in seconds. The answer was there; the references were there; nothing left to chase down."

    VP, Quality and Regulatory Affairs

  • "No process disruption. It works with your existing systems. Everything else wants you to change something about your system. This just works with the existing systems you have. Sofie supports versus changes."

    VP, Manufacturing

  • "Sofie is a CMC orchestrator. Instead of manual workflows and separate systems, I can do various workflows in one place."

    Sr. Manager, CMC Operations

  • "Mapping out CPPs and CQAs for our tiered control strategy used to be a tedious, manual exercise. Sofie automates the risk assessment matrices and synthesizes our DoE results, turning a multi-day reporting process into a quick, review-ready output."

    Senior Scientist, Process Development

  • "What used to take me half a day searching through guidance's and cross-referencing documents, Sofie handled in seconds. The answer was there; the references were there; nothing left to chase down."

    VP, Quality and Regulatory Affairs

  • "No process disruption. It works with your existing systems. Everything else wants you to change something about your system. This just works with the existing systems you have. Sofie supports versus changes."

    VP, Manufacturing

  • "Sofie is a CMC orchestrator. Instead of manual workflows and separate systems, I can do various workflows in one place."

    Sr. Manager, CMC Operations

  • "Mapping out CPPs and CQAs for our tiered control strategy used to be a tedious, manual exercise. Sofie automates the risk assessment matrices and synthesizes our DoE results, turning a multi-day reporting process into a quick, review-ready output."

    Senior Scientist, Process Development

  • "What used to take me half a day searching through guidance's and cross-referencing documents, Sofie handled in seconds. The answer was there; the references were there; nothing left to chase down."

    VP, Quality and Regulatory Affairs

  • "No process disruption. It works with your existing systems. Everything else wants you to change something about your system. This just works with the existing systems you have. Sofie supports versus changes."

    VP, Manufacturing

  • "Sofie is a CMC orchestrator. Instead of manual workflows and separate systems, I can do various workflows in one place."

    Sr. Manager, CMC Operations

  • "Mapping out CPPs and CQAs for our tiered control strategy used to be a tedious, manual exercise. Sofie automates the risk assessment matrices and synthesizes our DoE results, turning a multi-day reporting process into a quick, review-ready output."

    Senior Scientist, Process Development

  • "Sofie's becoming my go-to tool — I use it for statistical calculations, contract verbiage, budget variance, all of it."

    VP of Technical Operations

  • "Sofie is one central, intelligent solution. Instead of manual workflows and separate systems, I can manage all of my CMC functions and protocols in one place."

    VP, Quality

  • "75% of what we do as CQV engineers is just trying to get information out of documents and into a different package. Sofie gives engineers the time back to do what matters — actual thinking about how we want to be testing this system."

    Principal CQV Engineer

  • "Sofie automated workshop coordination — easily our most time-consuming task — and gave me back four hours in a single week."

    Technical Operations Manager

  • "Sofie's becoming my go-to tool — I use it for statistical calculations, contract verbiage, budget variance, all of it."

    VP of Technical Operations

  • "Sofie is one central, intelligent solution. Instead of manual workflows and separate systems, I can manage all of my CMC functions and protocols in one place."

    VP, Quality

  • "75% of what we do as CQV engineers is just trying to get information out of documents and into a different package. Sofie gives engineers the time back to do what matters — actual thinking about how we want to be testing this system."

    Principal CQV Engineer

  • "Sofie automated workshop coordination — easily our most time-consuming task — and gave me back four hours in a single week."

    Technical Operations Manager

  • "Sofie's becoming my go-to tool — I use it for statistical calculations, contract verbiage, budget variance, all of it."

    VP of Technical Operations

  • "Sofie is one central, intelligent solution. Instead of manual workflows and separate systems, I can manage all of my CMC functions and protocols in one place."

    VP, Quality

  • "75% of what we do as CQV engineers is just trying to get information out of documents and into a different package. Sofie gives engineers the time back to do what matters — actual thinking about how we want to be testing this system."

    Principal CQV Engineer

  • "Sofie automated workshop coordination — easily our most time-consuming task — and gave me back four hours in a single week."

    Technical Operations Manager

A pilot that works on day one

A pilot that works on day one

In one hour, your team is live. One week to see your work multiply. Sofie is built for biopharma teams from day one, not day ninety. Your first result comes from your first conversation.

In one hour, your team is live.
One week to see your work multiply.
Sofie is built for biopharma teams from day one, not day ninety. Your first result comes from your first conversation.

In one hour, your team is live. One week to see your work multiply. Sofie is built for biopharma teams from day one, not day ninety. Your first result comes from your first conversation.

Book a demo

Don’t change how you work,
change what you’re working with.

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