Product · AI Framework for Pharma
A modular, GxP-governed framework that combines vertical AI agents with named senior experts across regulatory writing, clinical R&D, and pharmacovigilance — delivered through a unified command center your teams and auditors can trust.
The Framework
Catalyst Pods stack AI, governance, and expert accountability into a single operating model — so every output is defensible, auditable, and delivered on outcome.
Fine-tuned, evaluated agents purpose-built for regulated pharma workflows — not general-purpose chatbots.
21 CFR Part 11 audit trails, GAMP5-aligned validation, and role-based controls wired into every action.
A senior medical writer, clinical scientist, or PV specialist owns every output. No anonymous review.
One dashboard for intake, agent runs, human review, evidence, and metrics — across every pod you deploy.
The Pods
We go deep, not wide. Each pod is scoped to the documents that gate approvals — and staffed with the seniority regulators expect.
Submission-ready CSRs, safety narratives, and CTD summaries — drafted by validated agents, signed by senior medical writers.
Protocols, amendments, and clinical documentation with agent-assisted drafting and human QC — every artifact traceable and audit-ready.
Case intake, narrative generation, signal support, and submission publishing — governed by an FDA-defensible operating model.
Command Center
Watch a real workflow move from intake to submission — agents drafting, experts reviewing, evidence captured — all in a centralized platform your quality team can inspect at any time.
Engagement Model
Four ways to adopt Catalyst Pods — each gated on measurable results before you commit to the next.
We map your critical-path documents, identify the highest-leverage pod, and scope a pilot with clear outcome metrics.
One pod, one workflow, real documents. Fixed fee, fixed scope, measurable outcome — first-pass QC and cycle-time.
A dedicated Catalyst Pod embedded in one function. Predictable capacity, SLAs on cycle time, cancel or resize quarterly.
Scaled pods across your regulatory and clinical functions. Governed by your quality system, priced on outcomes.