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Solutions & Products

At Amia.ai, we develop domain-trained AI for life sciences. Whether you’re a pharmaceutical innovator, biotech trailblazer, or strategic CRO/CMO, we help accelerate regulatory workflows, reduce costs, and improve submission readiness.

AI & Regulatory Consultancy

We guide your teams from vision to deployment:
  • AI Strategy & Roadmapping – Identify automation-ready opportunities
  • Pilot-to-Scale Execution – Stand up AI agents that deliver fast ROI
  • Training & Change Enablement – Equip your team to work alongside AI

Clinical & Regulatory AI Solutions

Purpose-built for the most critical functions in life sciences:
  • Clinical Study Report (CSR) Automation – Generate ICH E3–compliant CSRs in hours—not weeks
  • Regulatory Intelligence CoPilot – Real-time monitoring of FDA, EMA, ICH guidance—auto-summarized and actionable
  • Sponsor-Ready Document Generation for CROs & CDMOs – MedNova AI Agents help contract partners deliver faster, compliant outputsactionable

Products

Our Products

Your AI Platform for Regulatory Documentation and Planning

The MedNova platform accelerates the creation and review of complex regulatory documents — from early development to market approval.

It’s built to help life science teams plan, draft, and validate submission-ready content across all key document types including Pre-IND, IND, NDA/BLA, and CMC.

Gap Analysis Tool

Find and fix gaps before submission

  • Automatically identifies missing data, inconsistencies, and structural issues across regulatory documents
  • Benchmarks your content against FDA and ICH expectations for completeness and compliance
  • Generates actionable, traceable reports with clear recommendations
  • Reduces risk of review delays and costly resubmissions

Compliant Document Generator

Draft high-quality regulatory documents in a fraction of the time

  • Produces submission-ready drafts using validated, domain-specific LLM templates
  • Ensures outputs are reviewable, auditable, and aligned with regulatory standards
  • Accelerates writing cycles and reduces reliance on external vendors
  • Seamlessly integrates with internal review and approval workflows

MedNova

Your AI Copilot for regulatory documentation and planning

  • Draft NDA, IND, and CMC documents with LLM accuracy
  • Output is traceable, reviewable, and submission-ready
  • Cuts hours from writing cycles, reduces outsourcing costs

BioPharmLLM

A vertical language model trained on clinical and regulatory data

  • Understands life sciences-specific terminology
  • Surfaces competitive, clinical, and scientific insights fast
  • Powers tools like dashboards, search, and summarizers