Solutions
One system of work,shaped to each team.
The same platform carries quality records, regulatory submissions, transfers and client proposals. What changes is the work, the standards and the people who review it.
By team
For the functions behind every batch
By organization
For the way your company operates
Ready on day one
Over a hundred workflows, built by operators.
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
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.