Amia.ai

Amia.ai develops artificial intelligence solutions specifically designed for pharmaceutical, biotechnology, medical device, and diagnostics companies. The company focuses on automating regulatory documentation and submission workflows using domain-trained large language models that understand FDA, EMA, and ICH regulatory requirements.

The company's core offerings include automated Clinical Study Report generation, regulatory intelligence monitoring, and IND/NDA submission acceleration tools. Their flagship product, MedNova, produces submission-ready regulatory documents using templates validated against regulatory standards. BioPharmLLM, their vertical language model, is trained on clinical and regulatory data to understand life sciences-specific terminology.

Amia.ai has delivered implementations for companies including Amgen, Gilead, and several clinical-stage biotech firms. Client testimonials reference reductions in submission preparation time and the ability to redeploy PhD-level staff from administrative tasks to research activities. The company deploys solutions on cloud platforms (AWS, Azure, GCP) as well as on-premise environments.

Amia.ai is positioned for organizations that need regulatory submission workflows automated by AI systems trained on pharmaceutical documentation standards. Companies report reductions in NDA submission preparation time by 40% and generation of stability tables in minutes rather than weeks.

The combination of domain-trained language models and regulatory expert oversight addresses the unique compliance requirements of pharmaceutical submissions. Organizations with substantial regulatory documentation workloads and access to experienced medical writers for review may see the strongest return on investment.

Amia.ai operates exclusively within the life sciences sector, focusing on pharmaceutical, biotech, medical device, and diagnostics companies. Their solutions address FDA and EMA regulatory requirements including IND/NDA submissions, Clinical Study Reports compliant with ICH E3 standards, and medical device submissions (510(k), PMA). The company's language models are trained specifically on regulatory guidance documents from FDA, EMA, and ICH.

Client testimonials come from regulatory executives at RNA therapeutics companies, immuno-dermatology biotechs, and AI-driven drug discovery firms. The regulatory intelligence tools monitor changes in FDA, EMA, and ICH guidance documents with real-time alerts for compliance teams.

Mid-to-large pharmaceutical companies, commercial-stage biotech firms, and established CROs/CDMOs with recurring regulatory submission needs. Organizations with teams of PhD-level scientists spending significant time on administrative documentation tasks rather than research. Companies preparing for IND, NDA, BLA, 510(k), or PMA submissions who need to reduce reliance on external medical writing consultants.