Biolevate
Biolevate provides an enterprise-grade agentic platform that automates evidence-grade document authoring and regulatory workflows for life sciences organizations. The platform generates first-pass drafts of clinical protocols, CSRs, PSURs, HTA dossiers, and regulatory submissions with source-linked traceability and human-in-the-loop review, capable of running 100,000 concurrent agents.
- AI Agents
- Artificial Intelligence
- Regulatory & Compliance Technology
- Software Only
- Biotechnology
- Healthcare Technology
Funding
Raised to date
€36MRaised 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.
Est. $39.2Macross 2 rounds
MGMGRF+1€30M · Series A
Announced Sep 2026
Disclosed cumulative: $39.2M
Founders
Product
Problem
Life sciences organizations face significant productivity bottlenecks in high-stakes, regulated document authoring and review processes. Requirements are fragmented across multiple sources—such as investigator brochures, prior protocols, regulatory guidance, safety data, and statistical assumptions—making consolidation, consistency, and version control difficult. Manual workflows for clinical protocols, clinical study reports (CSRs), regulatory dossiers, and health technology assessments (HTAs) are slow, error-prone, and constrained by limited medical writing capacity.
Solution
Biolevate provides a hyperspecialized, enterprise-grade agentic platform that transforms complex scientific and regulatory knowledge into evidence-grade, auditable workflows. The platform generates first-pass document sections into governed templates while preserving source-linked rationale and reviewer control, supporting human-in-the-loop co-authoring across clinical protocols, CSRs, PSURs, regulatory dossiers, and HTA submissions. It also automates evidence gap mapping, regulatory change monitoring, safety signal surveillance, and competitive intelligence by grounding outputs in approved source evidence with full run-record auditability. The platform is capable of running 100,000 agents concurrently and delivers measurable impact, including 2× faster protocol drafting, up to 50% less first-draft effort for CSRs, and 16× faster decision reviews for HTA assessments.
Target Audience
Primary customers are life sciences organizations, including pharmaceutical companies, biotech firms, and contract research organizations, specifically medical writing, clinical development, regulatory affairs, pharmacovigilance, HEOR, and market access teams.
Features
- Human-in-the-loop co-authoring that generates first-pass sections into governed templates while preserving source-linked rationale and reviewer control
- Source-linked traceability for every drafted section, claim, and data point, with run-record auditability for regulatory compliance
- Automated consistency checks across objectives, endpoints, eligibility criteria, safety sections, and statistical assumptions before cross-functional review
- Evidence gap mapping with claim-to-evidence matrices and gap heatmaps to prioritize next evidence-generation actions by market
- Regulatory change monitoring and impact mapping that automates the assessment of fragmented frameworks on existing portfolios
- Safety signal surveillance and triage with automated classification and prioritization against product benefit-risk profiles
- Template governance aligned with internal standards, regulatory expectations, and study-specific writing rules
- Scalable agentic architecture capable of running 100,000 concurrent agents for enterprise-wide deployment