Zenopsys is the AI-Native documentation workspace for authoring, reviewing, and submitting every document across drug development - clinical protocols, CSRs, and full eCTD dossiers (IND, ANDA, NDA, MAA). Built for pharma innovators, generics manufacturers, and regulatory consultants worldwide.
Problem Statement:
Regulatory documentation in life sciences is still entirely manual for 40,000+ Products and 15,000+ Companies. 100s of documents, 10,000s of pages, & a process that restarts from scratch with every change. It's the single biggest bottleneck between a finished drug and its approval. Moreover, Regulators like FDA and EU are already started using AI. So, it's time to shift the regulatory industry towards the AI for the global submissions
Possible Solutions:
eCTD Authoring: Modules 1–5 of CTD submissions with built-in ICH compliance & cross-module checks.
AI Review (Regulator): Review agents that scan every section for gaps, inconsistencies and FDA-style red flags.
Private Regulatory Chat: Secure interface over the largest regulatory guidance library & your internal data.
Medical Writing Agents: Literature search, clinical summaries, benefit-risk summaries for global submissions
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