CMC

Weeks, not quarters, to file. Structured CMC data assembly turns the scramble of pulling a submission together into a repeatable, fast process.

Back

CMC

Weeks, not quarters, to file. Structured CMC data assembly turns the scramble of pulling a submission together into a repeatable, fast process.

Back

The Challenge

A submission comes together by hand, reassembled each time from data spread across every system that touched the product.

A CMC filing draws on process, analytical, and quality evidence generated over years and across systems. When that evidence lives in separate places, every submission becomes a manual reassembly: the same records hunted down, reconciled, and reformatted from scratch under deadline.

The Katalyze Approach

One connected record turns the submission into a repeatable assembly, traceable to source.

The Context Layer holds the product's process, analytical, and quality history as one connected, source-anchored record. When it is time to file, the evidence is already assembled and tied to its origin, so the submission is built from a structured record instead of reconstructed by hand.

The Results

40+

Systems connected, from LIMS to paper and Excel

5 of 20

The largest global pharma companies, building on Katalyze

2weeks

Live on your existing stack, not months

Deployed at sites with five of the top
twenty global pharma companies

Turn confusion into clarity, today.

Book a 30-minute demo. We'll walk through a live run, deviation to release record, and map Katalyze to the systems you already have. Most teams are live in weeks.

Deployed at sites with five of the top
twenty global pharma companies

Turn confusion into clarity, today.

Book a 30-minute demo. We'll walk through a live run, deviation to release record, and map Katalyze to the systems you already have. Most teams are live in weeks.

Deployed at sites with five of the top
twenty global pharma companies

Turn confusion into clarity, today.

Book a 30-minute demo. We'll walk through a live run, deviation to release record, and map Katalyze to the systems you already have. Most teams are live in weeks.