Cytodyme provides AI-enabled software to automate post-market quality and regulatory workflows for MedTech companies. The platform centralizes complaint management, literature surveillance, and vigilance activities within a single, FDA 21 CFR Part 11 compliant system. This automation reduces manual documentation burden while ensuring audit-ready traceability for MDR/IVDR reporting requirements like PSUR and CER.
Funding
Funding not disclosed
Founders
Product
Problem
Translating research processes into cGMP-compliant manufacturing procedures is a time-consuming and complex bottleneck for biotech companies and academic labs developing cell and gene therapies. Identifying and onboarding with a suitable Contract Development Manufacturing Organization (CDMO) further delays the clinical development timeline.
Solution
Cytodyme offers a software platform designed to accelerate the clinical translation of cell and gene therapies. The platform automates the generation of cGMP-compliant batch records from user-defined processes, significantly reducing the time required for process documentation. Cytodyme also connects biotech innovators with appropriate CDMOs, streamlining the selection and onboarding process. By automating batch record generation and facilitating CDMO partnerships, Cytodyme aims to reduce bottlenecks and inefficiencies in clinical development, enabling faster delivery of personalized therapies.
Target Audience
The primary target audience includes small to mid-sized biotech companies and academic labs involved in cell and gene therapy development.
Features
- Automated generation of cGMP-compliant batch records from user-defined process inputs.
- Intuitive software interface designed for ease of use and rapid process translation.
- Matching algorithm to connect biotech innovators with suitable CDMO partners based on specific needs and capabilities.
- Secure, local data storage of process information.
- Streamlined communication and collaboration tools for innovators and CDMOs.