AI Agent for Biologics
CMC Development

An AI-driven CMC Agent to drive faster, more efficient biotherapeutics development — from IND through BLA/MAA submission.

Request a Demo See How It Works
Why It Matters

Chemistry, Manufacturing & Control is a leading cause of IND and BLA delays

CMC is among the most complex, time consuming, and error prone aspects of biologics development. PredyctBio was built to change that.

5
Development phases covered, Preclinical through BLA/MAA
10+
Biologic modalities supported
Global
Aligned with FDA, EMA, Health Canada, MHRA, PMDA, TGA, ICH and WHO guidelines
Capabilities

Everything your CMC team needs, in one agent

PredyctBio guides your team through the right documents, at the right stage, with regulatory context built in.

📋

Phase Gated Guidance

Know exactly which CMC deliverables are required at Preclinical, Phase 1, Phase 2, Phase 3, and BLA/MAA — and in what order to tackle them.

⚗️

Modality Aware

Guidance adapts to your specific biologic modality — covering the full range of biologics and vaccines in development today.

📄

GMP Grade Content

Built on SOPs, batch records, and regulatory documentation licensed from leading academic institutions — not generic web content.

🌐

ICH & CTD Aligned

Every recommendation is mapped to the ICH CTD structure (3.2.S, 3.2.P, 3.2.A) and updated for the M4Q(R2) framework.

🔗

Document Dependency Tracking

Understand which documents feed into each other — so nothing falls through the cracks when you're preparing for a regulatory submission.

🔒

Secure & Private

Your data stays yours. Client IP is never used for model training. Each engagement is isolated and protected.

Built for

CMC professionals at every stage of development

Whether you're filing your first IND or preparing for a BLA submission, PredyctBio provides the regulatory context and document scaffolding your team needs.

Request a Demo Learn More