Solutions · CDMOs
More programs per site,without more headcount.
From the first RFP to batch disposition, Sofie carries each client program across business development, tech transfer, quality and operations, with every client's work kept in its own workspace.
Workspaces / Tech Transfer
LB-204 Tech Transfer
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Name · ModifiedWorkspaces: every program's files, conversations, deliverables and meetings in one place.
ACDMOrunsmanyprogramsatonce,eachwithitsownclient,standardsandhistory.Sofiekeepseachonestraight,soyourteamscantakeonmorewithoutlosingthethread.
Work Sofie takes on
Work Sofie takes on across a CDMO
A cross-functional set from the Workflow Library, following a client program from proposal to release.
01
Proposal / RFP Response
Business Development · Workflow
Drafts or independently reviews a written response to a client RFP, RFI, RFQ, or an unsolicited/proactive proposal — end to end — so BD can move from solicitation to a review-ready proposal in one run, grounded strictly in supplied evidence.
Configured to your procedures
02
Technical Feasibility Assessment
Business Development · Workflow
Turn an incoming enquiry and your own site evidence into a defensible technical feasibility assessment — fit, capacity, gaps, risks and conditions — in an afternoon, not three weeks of round-robin emails.
Manual effort today
Two to three weeks of chasing MSAT, QC, QA and engineering for opinions, assembled into a document that quietly asserts capability nobody evidenced
03
Statement of Work (SOW)
Business Development · Workflow
Turn your engagement notes and service offering into a tightly scoped SOW — in an afternoon, not weeks.
Manual effort today
10–20 hours drafting and negotiating scope across BD and delivery
04
Tech Transfer Charter Generator
Tech Transfer · Generator
Authors a GMP-compliant Tech Transfer Charter — the governing document establishing scope, objectives, roles, deliverables, risk management, and stage-gate governance for a technology transfer engagement between an innovator and receiving site.
Estimated time saved
~20–35 hrs per TTC document
05
Process Transfer Plan Author
Tech Transfer · Author
Authors a GMP-compliant Process Transfer Plan in a single-agent, two-task run: extracts the controlled PTP Platform template's field schema dynamically, mines the Process Transfer Workspace (plus any Reference Documents and Governing Procedure) for process descriptions, batch records, analytical methods, equipment specifications, and stability data using dual-path reading, then authors and instantiates every discovered field — ensuring structural fidelity to quality system.
Estimated time saved
~25–40 hrs per PTP document
06
Quality Agreement
Quality Records · Workflow
Drafts or independently reviews a GMP Quality Agreement between a contract giver (product owner / MAH) and a contract acceptor (CDMO / CMO / contract lab), allocating GMP responsibilities, quality-system interfaces, and regulatory commitments.
Configured to your procedures
07
Deviation Investigation & CAPA
Quality Records · Workflow
Turn the event evidence — batch records, lab and OOS data, deviation logs, and governing SOPs — into an inspection-ready deviation investigation and CAPA plan: problem statement, timeline, evidence-bound root cause, SISPQ/product-impact assessment, and a CAPA plan, drafted and reconciled for QA review in an afternoon, not weeks.
Manual effort today
Days to weeks across QA and the investigation owner
08
Change Control
Quality Records · Workflow
Turn a change request and whatever evidence you already have into an inspection-ready change control record — impact assessed across every system the change touches, classified against your own matrix, and reportability called — drafted and reconciled in an afternoon.
Manual effort today
Two to three weeks of meetings
09
Project Management Dashboard
Business Operations · Workflow
Turn your schedule, risk, and action logs into a sign-off-ready status report and a live dashboard — in minutes, not days.
Manual effort today
4–8 hours per cycle compiling and reconciling status by hand
A day in the life
The same work, without the assembly.
Your experts still make every call. Sofie gathers the evidence, drafts in your format and marks what is missing.
Winning the work
Proposals grounded in what the site can actually do
- Before
- BD writes the proposal, then operations discovers what was promised.
- With Sofie
- Sofie drafts the proposal and feasibility assessment from the site's real capabilities and flags commitments that need operations sign-off.
Onboarding a client
Transfer starts with a complete picture
- Before
- The client's package is read piecemeal, and gaps appear during the first batches.
- With Sofie
- Sofie reads the full package into the program workspace, drafts the charter and transfer plan, and lists the gaps to close first.
Client meetings
Decisions captured and followed through
- Before
- Notes are written up after the call, and actions live in individual inboxes.
- With Sofie
- CoMeeting transcribes the session and drafts client-ready notes, with decisions and owners ready for follow-up.
“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.”
The platform behind it
Part of one connected platform
Workspaces
Every program, site and client, with its files, people and history in one place.
Orchestrations
Specialized agents coordinated across multi-step work, with human review points.
CoMeeting
Live transcripts, notes and follow-through for every working session.
Surfaces
Decks, dashboards, pages and live trackers built from a conversation.
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.