Alchemi provides an AI‑driven platform that automates regulated drug‑development workflows such as regulatory authoring, QC/QA data review, and data integration. Its purpose‑built scientific agents learn organization‑specific templates and SOPs, operate in a human‑in‑the‑loop mode, and maintain 21 CFR Part 11, SOC 2, ISO 27001, and GDPR compliance while integrating with existing LIMS, ELN, RIM, and SharePoint systems.
Funding
$3.3M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Drug development teams face lengthy, manual, and compliance‑heavy processes for document authoring, data review, and regulatory submissions, leading to delayed timelines and high costs.
Solution
Alchemi offers an AI‑driven platform that deploys specialized scientific agents to automate key R&D workflows such as regulatory authoring, QC/QA review, and data integration. The agents operate in a human‑in‑the‑loop mode, learning organization‑specific templates, SOPs, and ontologies to generate draft documents, flag compliance issues, and validate data integrity. Built‑in 21 CFR Part 11 compliance, audit trails, and enterprise‑grade security (SOC 2, ISO 27001, GDPR) ensure that all activities meet regulated standards. Seamless integration with existing systems (LIMS, ELN, RIM, SharePoint) and a shared, GxP‑compliant collaboration space enable teams to adopt the technology without disrupting current processes. The platform can be customized and production‑ready within two weeks, continuously improving through adaptive optimization and human feedback.
Target Audience
Primary customers are pharmaceutical and biotech R&D teams, including non‑clinical, clinical, bioanalysis, CMC, and regulatory groups, as well as CROs and CDMOs that require regulated, automated documentation and data review solutions.
Features
- AI agents for regulatory authoring that reduce documentation time by up to 90% using template learning and human‑in‑the‑loop validation
- Automated QC/QA review that flags compliance with guidelines, study‑specific criteria, and internal SOPs across thousands of data points in seconds
- Built‑in compliance framework (21 CFR Part 11, audit trails, role‑based permissions) with full GxP, SOC 2, ISO 27001, ISO 9001, and GDPR certifications
- Secure, single‑tenant deployment with end‑to‑end encryption, zero data retention by AI models, and comprehensive audit logging
- Integration layer that connects agents to existing scientific systems (LIMS, ELN, RIM, SharePoint) and extracts key terms from diverse document types
- Collaborative shared spaces for secure document analysis, retrieval, and team interaction within a compliant environment
- Adaptive optimization cycle that refines agent performance through real‑world usage and continuous human feedback