From FDA-trained Regulatory Intelligence Copilots to custom AI workflows — we help R&D, clinical, and regulatory teams move faster with confidence
services
At Amia.ai, we develop AI solutions that are custom-built for real business impact.
Accelerate regulatory milestones, reduce submission costs, and limit FDA review cycles.
Automate Clinical Study Reports from source to ICH E3–compliant, submission ready output—accurate and formatted within hours.
Regulatory Intelligence CoPilot tracks FDA, EMA, and ICH guidance—automatically monitors, summarizes, and alerts your team to global changes in real time.
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Streamlined pharma regulatory submissions beyond ChatGPT.
Life science intelligence powered by large language models trained on industry-specific data.
Conversational AI for small biotech/CRO/CMO to handle routine customer service and medical info requests with ease.
industries
Amia builds industry-trained AI for pharma, biotech, medical devices, and diagnostics—designed to fit real-world workflows.
Specialized services for R&D, regulatory affairs, and medical writing teams.
AI-Powered Automation for 510(k), PMA, and DHF Submissions Accelerate FDA Clearance with Confidence.
Generate Analytical and Clinical Validation Reports for 510(k) and PMA with AI Precision
features
Build by Pharma, Powered by AI
We’re backed by a network of PhD, PharmD, and MD-level advisors with decades of experience in regulatory writing, CMC, clinical development, and FDA/EMA submissions.
Delivering domain-trained AI solutions powered by global engineering talent and deep life sciences knowledge.
We custom build to the cloud (AWS, Azure, GCP) and On-Premise
See real case studies in retail, pharma submissions, and F&B to learn what AI can achieve with the right partner.
testimonial
At Amia.ai, we develop AI solutions that are custom-built for real business impact.
Chief of Staff at a Clinical-Stage Biotech backed by top-tier VCs
(Focused on immuno-dermatology, publicly traded with several late-phase clinical trials)
Regulatory Executive at a $5B Commercial-Stage Biotech
(Specializes in RNA-targeted therapeutics for rare and neurological diseases, headquartered in Southern California. The cost of Mednova pays for itself—in just one month, it offsets the lost productivity of even a single PhD’s time.)
Chief of Staff at a Clinical-Stage Biotech backed by top-tier VCs
(Focused on immuno-dermatology, publicly traded with several late-phase clinical trials)
Senior Director of Regulatory Strategy at an AI-Driven Public Biotech
(Combines deep learning and automated biology for drug discovery across oncology, inflammation, and rare disease — headquartered in Utah)
process
We explore your business and identify AI opportunities.
We outline a clear AI integration path.
Low-risk, fast-implementation pilots.
Full rollout into your existing tech stack.
Continuous training, tuning, and support.
resources
Life sciences can’t afford delays—and AI isn’t optional.
Amia AI delivers advanced, business-ready AI solutions that streamline operations, boost efficiency, and drive profitable growth.
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