Cytodyme is an AI-powered clinical development and regulatory platform designed to automate document generation and compliance workflows for life science and biotech companies. The platform focuses on streamlining the path from research to manufacturing by automating the creation and management of SOPs, batch records, material specifications, and regulatory reports such as IND submissions and post-market surveillance (PMS) documents. Specifically built for the cell and gene therapy and medtech sectors, Cytodyme's software integrates with existing quality and data sources to maintain continuity across workflows. It aims to reduce the cost of life-saving therapies by eliminating the manual burden of regulatory documentation and ensuring audit readiness through AI-driven traceability and version control.
CLASSIFICATION
Company Type:Digital Health
Therapeutic Areas:
Industry:Digital Health
Sub-Industry:Regulatory Compliance Software / AI for Life Sciences
SIZE & FINANCIALS
Employees:1-50
Revenue:Generating Revenue
Founded:2024
Ownership:private
Status:operating
FUNDING
Stage:Seed
Total Raised:$0.31M
Investors:Techstars, Angel Investors
PIPELINE
Stage:Commercial
Lead Drug Stage:N/A (Software Platform)
Modalities:Software-as-a-Service (SaaS), AI/ML Automation
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Key Partnerships:EmerRx BioPharma (Early access partner and product advisory collaborator)
COMPETITION
Position:Emerging
Competitors:Veeva Systems, MasterControl, Qualio, Greenlight Guru, Klira AI
LEADERSHIP
Key Executives:
Dennis 'D.J.' White - CEO & Co-founder
Tammy Ogden - CBO & Co-founder
Stephen Brown-Bourne - CTO & Co-founder
Scientific Founders:Dennis White
Board Members:Dennis White, Tammy Ogden
LINKS
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