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.
PredyctBio walks your team through CMC development step by step — asking the right questions, in the right order, for your program.
Tell the agent your modality, development phase, and target regulatory agencies.
See which CMC documents are suggested and where the critical path dependencies lie.
Work through individual documents with the agent — regulatory context and ICH-aligned guidance built in.
As your program advances, the agent updates your document map to reflect new requirements at each phase.
PredyctBio maps over 80 CMC deliverables from Preclinical through BLA/MAA — showing document relationships, phase gates, and dependencies in a single connected graph.