Agentic AI for CMC teams
Your data already has the answers your team needs. It's spread across hundreds of Excel files and PDFs, plus LIMS, MES, QMS and ERP, and pulling it together takes days. AI agents do it in minutes.
What workflow eats your team's time?
Each page has the recurring problem in your own vocabulary, a short demo of an agent working it, and what it takes to run it on your data.
Manufacturing
Ten minutes to assemble a deviation investigation, not ten days.
InvestigateQuality Assurance
Every open deviation, CAPA and OOS against a batch, in one place before you disposition it.
DecideQuality Control
Stability trends projected before an attribute crosses spec.
ProjectAnalytical Development
Whether the method is precise enough for the limit it is judging.
AnalyzeProcess Development
The registered ranges your characterization data does not support.
CompareTech Transfer
The development package against the GMP process, line by line.
ReconcileRegulatory Affairs
Module 3 sections drafted from prior submissions and current data.
DraftA deviation investigation, conducted in minutes.
What you're watching: the agent opens a deviation record in the QMS, pulls the batch record and process parameters for that lot from the MES, pulls the associated release and in-process results from the LIMS, then lines the lot up against comparable batches and returns a timeline with the candidate causes ranked and the evidence for each one cited back to its source record. The agent prepares a draft report, including findings, RCA, CAPAs and conclusion. Ready for human review.
Start with a diagnostic.
Every engagement starts with the Data Diagnostic: a fixed-fee, two-to-three week assessment of whether your data and systems can actually carry the initiative you're already funding. What follows is either project work to close the gaps it finds, or a fractional retainer if you want senior data and AI leadership on hand without adding headcount.
See the diagnostic, including the price
Your IT and quality systems group will have questions before this goes anywhere. I've written the answers down.
Architecture, read and write paths, Part 11 and ALCOA+, validation approach, model governance, and the things I explicitly don't do. Forward the link or hand over the PDF.
Read the governance and validation pageTell me what your team spends its week on.
Thirty minutes. I'll tell you whether an agent can run that workflow today, and what your data would have to look like first.
30 minutes on your workflow, no pitch →