Customers
The teams behindthe medicines, at work.
CDMOs, emerging biotechs and biopharma teams use Sofie for the work behind every batch and submission: quality records, regulatory responses, transfers and the operations around them.
Featured customer
INCOG Biopharma
00:00:00:00
Customer story · Cory Lewis, CEO · In production
INCOG Biopharma × Sofie
“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.”
Across our customers
Measured in hours given back.
- 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
Strategic partnership · May 2026
Calidi Biotherapeutics
and TransferAI
- Program
- CLD-401
- Focus
- IND preparation
Partnership
Supporting the IND for CLD-401.
Calidi Biotherapeutics chose TransferAI to support regulatory preparation for the IND submission of CLD-401, the lead candidate from its RedTail platform. Sofie works alongside Calidi’s teams across scientific, clinical and manufacturing documentation, with human oversight at every critical decision point.
“We believe that TransferAI is the best partner to bring the power of agentic AI to support our regulatory efforts around CLD-401.”
Sofie at Work
Real workflows, told by the people who run them.
Our Sofie at Work series follows biopharma professionals through the work they hand to Sofie, step by step.
Case story ·
How one CDMO succeeded across three sites
A multi-site pilot across quality, regulatory, IT and operations, and the time each team got back.
- Method verification protocol
- 2–3 days10 minutes
- Weekly IT admin review
- 6+ hours15 minutes
- Deviation investigation review
- 45–60 minutes10 minutes
- Regulatory research
- 4–6 hours2 hours
Read the story
In their words
What leaders across operations say
“Sofie is the ultimate enabler. That leverage, compounded across the organization, is enormous.”
CEO, CDMO
“Complex questions used to take hours. Sofie brings the risk-based thinking and regulatory backing together instantly. My responses are sharper, faster, and defensible from the start.”
VP Quality & Regulatory, Biopharma
“Sofie changes everything, except the way you work. It just makes it a whole lot easier and faster.”
VP Manufacturing & Supply Chain, Biotech
“What used to take me half a day searching through guidances and cross-referencing documents, Sofie handled in seconds. The answer was there; the references were there; nothing left to chase down.”
VP Quality & RA
Your team’s story
starts with one workflow.
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.