AMIA develops custom AI solutions, including Regulatory Intelligence Copilots and automation tools, specifically for the pharmaceutical and biotech industries. These solutions accelerate regulatory milestones, automate Clinical Study Report generation, and monitor global guidance for R&D and regulatory teams. The company provides domain-trained large language models and expert consultancy to streamline complex submission processes for life science organizations.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical and biotech companies face significant time and resource constraints in preparing regulatory submissions and clinical study reports. The manual processes involved are prone to delays and can hinder the timely delivery of critical data to regulatory bodies.
Solution
Amia provides AI-powered solutions and expert consultancy tailored for the pharmaceutical and biotech sectors. Their platform accelerates the generation of regulatory submission documents, automates the creation of Clinical Study Reports (CSRs) to ICH E3 compliance, and delivers real-time regulatory intelligence by monitoring global guidance updates. By leveraging domain-specific large language models (LLMs) trained on extensive regulatory data, Amia empowers R&D, clinical, and regulatory teams to enhance operational efficiency and expedite their product development timelines. The solutions are designed for seamless integration into existing workflows, offering custom-built deployments on cloud or on-premise infrastructure.
Target Audience
Amia serves R&D, clinical, and regulatory affairs teams within pharmaceutical, biotech, medical device, and diagnostics companies, as well as Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs).
Features
- **IND/NDA Submission Acceleration:** Streamlines the preparation of Investigational New Drug (IND) and New Drug Application (NDA) dossiers, reducing submission cycle times.
- **Clinical Study Report (CSR) Automation:** Generates ICH E3-compliant CSRs from source data within hours, significantly reducing manual authoring effort.
- **Regulatory Intelligence Copilot:** Continuously monitors and summarizes updates from regulatory agencies like the FDA, EMA, and ICH, providing real-time alerts on changes in guidance.
- **Domain-Trained AI Models:** Utilizes LLMs specifically trained on pharmaceutical and biotech data, ensuring accuracy and relevance for life sciences applications.
- **Customizable Deployment:** Offers flexible deployment options on major cloud platforms (AWS, Azure, GCP) or on-premise environments to meet specific IT and security requirements.
- **Expert-Guided Development:** Solutions are developed with input from domain experts, including PhDs, PharmDs, and MDs with extensive experience in regulatory affairs and clinical development.
- **AI Agents for Specific Tasks:** Provides specialized AI agents, such as MedNova for submission acceleration and ChatAmia for customer service and medical information requests.