Your CMC knowledge. Productized.
Process development assistant trained on Inscinstech's v2.2 CMC knowledge base, FDA review documents, and your own historical batches. 21 CFR Part 11-ready.
CMC knowledge is tribal — and that's the problem.
Every process scientist carries 10 years of habits, preferences, unwritten rules.
When they leave, that knowledge leaves with them. When a new molecule arrives, half the team relearns it.
What if the knowledge stayed?
A copilot trained on real CMC.
InCortex absorbs Inscinstech's CMC v2.2 knowledge base (82+ entries), FDA review docs, and your team's batch records — as a process design copilot.
Five workflows across the CMC lifecycle.
From the initial process tree to the final IND/NDA document draft.
Process development assistant
User describes the molecule + target; the Agent recommends a process across capture / polish / viral / final steps — with resin, buffer, parameter ranges, risk flags, and alternatives per step. Backed by a real chromatography-column catalog and multi-tenant process records.
DoE design · execution · analysis
Live DoE workspace backed by a Gaussian-process + active-learning microservice: factors / responses, response surface, and a recommended next run. Writes to an auditable process record.
Impurity attribution + method development
Upload HPLC / MS data; the Agent attributes impurity sources (OligoMS approach) and recommends characterization methods + limits.
Risk assessment + ICH Q9 automation
FMEA / Risk Assessment templates + AI fill, outputs IND/NDA report drafts.
CMC document drafting
Development report · Process description · Specification draft generation, FDA / NMPA style-matched.
Competitive & pipeline intelligence · scheduled digests
Track a related company’s development pipeline and summarize updates as they land; compile a weekly industry-trend digest. One of the scheduled-task types — runs in the background and delivers to you on cadence.
GxP-ready from day one.
We didn't add compliance as an afterthought. It's a primary engineering constraint.
Three roles. Three force multipliers.
“Turns the P-2 → P-3 transition from trial-and-error into a few evidence-backed DoE rounds.”
“InCortex drafts the dev report; I spend my time on the decisions and the review.”
“A small team punches above its weight — InCortex keeps accumulated process know-how at hand.”
An InCortex process design.
Common questions
Stop relearning what you already know.
Start free — upgrade to Pro / Plus / Max any time.