Immunic Therapeutics Selects CARA Life Sciences Platform to Streamline Regulatory Operations and Accelerate Submissions
CARA Life Sciences Platform Adoption Continues to Grow with Biotech Organisation Immunic Therapeutics
Generis, the creator of the CARA Life Sciences Platform, today announced that Immunic, a fast-growing biotechnology company focused on treatments for immunologic diseases, has selected CARA to manage Regulatory Documents as the first phase of a broader digital transformation initiative.
Headquartered in New York City and with operations in the United States, Germany, and Australia, Immunic develops therapies for chronic inflammatory and autoimmune diseases such as multiple sclerosis, celiac disease and other neurologic and gastrointestinal disorders. Due to recent growth, Immunic started looking for a new way to manage documentation and data around Regulatory Operations.
“CARA will reduce manual effort, shorten submission cycles, and support our wider strategic goals. The intuitive interface and trusted delivery model will help us gain immediate process improvement while laying the groundwork for future digital expansion.” said Femke Sanders, Head of Regulatory Affairs & Pharmacovigilance at Immunic.
CARA replaces Immunic’s existing tools with a robust, unified platform for global compliance and growth. With built-in workflows, metadata-driven structures, and seamless Okta SSO integration, CARA provides:
- A single source of truth for regulatory documentation
- Improved submission tracking and real-time reporting
- Full audit readiness and traceability
- Minimal IT burden with fast, validated deployment
- Scalability across Clinical, Safety, and Quality functions
Immunic starts their project with CARA for Regulatory Document Management, with future phases to expand into Clinical and Safety operations. The CARA Life Sciences Platform provides a centralised, validated foundation that reduces administrative burden and allows Immunic’s teams to focus on science, not systems.
“We are proud to support Immunic in their journey to unify and scale regulatory operations,” said Max Kelleher, CEO of Generis. “The CARA Life Sciences Platform is designed to meet the needs of modern biotech companies—delivering compliance, usability, and flexibility from day one.”
About Generis
Generis is the developer of the CARA Life Sciences Platform, used by over 750,000 users worldwide across more than 100 countries. CARA provides a single platform to manage content, data, and processes across Regulatory, Quality, Safety, and Clinical functions—helping life sciences companies bring products to market faster while ensuring compliance and efficiency.
About Immunic
Immunic (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
