The Product

The Biologics CMC Agent

A guided AI agent that knows what CMC documents you need, when you need them, and what regulatory standard they have to meet — for your specific modality and development stage.

The Interface

A guided, conversational experience

PredyctBio walks your team through CMC development step by step — asking the right questions, in the right order, for your program.

PredyctBio AI Agent interface
How It Works

From program setup to submission-ready documents

1

Define Your Program

Tell the agent your modality, development phase, and target regulatory agencies.

2

Explore Your Deliverables

See which CMC documents are suggested and where the critical path dependencies lie.

3

Get Guided Authoring

Work through individual documents with the agent — regulatory context and ICH-aligned guidance built in.

4

Evolve as You Advance

As your program advances, the agent updates your document map to reflect new requirements at each phase.

CMC Deliverable Map

Every deliverable, across every phase

PredyctBio maps over 80 CMC deliverables from Preclinical through BLA/MAA — showing document relationships, phase gates, and dependencies in a single connected graph.

CMC deliverable graph — Preclinical through BLA/MAA

See it in action with your program

Want to see PredyctBio working against your actual development stage and program? Request a demo with our team.