services

What We Offer

At Amia.ai, we develop AI solutions that are custom-built for real business impact.

Services we provide

IND/NDA Submission Acceleration

Accelerate regulatory milestones, reduce submission costs, and limit FDA review cycles.

Clinical Study Report (CSR) Automation

Automate Clinical Study Reports from source to ICH E3–compliant, submission ready output—accurate and formatted within hours.

Regulatory Intelligence Copilot

Regulatory Intelligence CoPilot tracks FDA, EMA, and ICH guidance—automatically monitors, summarizes, and alerts your team to global changes in real time.

Sponsor-Ready Outputs for CROs & CDMOs (Contract Writers, CMOs, Data Teams)

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Our Products

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.

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Industries We Serve

Amia builds industry-trained AI for pharma, biotech, medical devices, and diagnostics—designed to fit real-world workflows.

Pharma & Biotech

Specialized services for R&D, regulatory affairs, and medical writing teams.

medical devices

AI-Powered Automation for 510(k), PMA, and DHF Submissions Accelerate FDA Clearance with Confidence.

Diagnostics

Generate Analytical and Clinical Validation Reports for 510(k) and PMA with AI Precision

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Why Choose Amia.ai

Build by Pharma, Powered by AI

Our solutions are guided by domain experts — not just engineers

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.

Where Life Sciences Expertise Meets World-Class AI Engineering

Delivering domain-trained AI solutions powered by global engineering talent and deep life sciences knowledge.

Custom- Built Solutions:

We custom build to the cloud (AWS, Azure, GCP) and On-Premise

AI implementation at Fortune 500 companies


See real case studies in retail, pharma submissions, and F&B to learn what AI can achieve with the right partner.

testimonial

Trusted by Industry Leaders in Regulatory Affairs

At Amia.ai, we develop AI solutions that are custom-built for real business impact.

process

How It Works

Discovery Call

We explore your business and identify AI opportunities.

Strategy Roadmap

We outline a clear AI integration path.

Pilot Program

Low-risk, fast-implementation pilots.

Deployment

Full rollout into your existing tech stack.

Ongoing Optimization

Continuous training, tuning, and support.

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Featured Case Studies