BioMedSA’s Board of Directors approved 5 new memberships in June 2023: CENIT Consulting, Clinical Trials of Texas, Galen Data, USI Insurance Services, and Phage Refinery.
CENIT Consulting seeks to provide comprehensive regulatory and quality management services specifically tailored for medical device start-ups. Drawing from our expertise in medical device regulatory affairs, they guide companies through the intricate landscape of regulations (particularly FDA and EU), helping them navigate the necessary processes to obtain the required certifications and approvals. They provide expert guidance in establishing robust Quality Management Systems that are tailored to a company’s specific needs and compliant with applicable regulatory requirements. They seek to empower medical device companies to make well-informed decisions, mitigate risks, and expedite their path to market.
Clinical Trials of Texas (CTT) is a multi-therapeutic clinical research site in San Antonio that conducts research studies in Phases I-IV. Founded in 2001, the site has grown to become one of the largest sites in the U.S. CTT was sold in 2001 to become the platform site of Flourish Research,. which now has wholly-owned, best-in-class sites across 6 states and 12 sites. CTT has been honored from multiple sectors for its excellence including Top Workplace in San Antonio, Fast-Track Business, Site Participant Recruitment Innovation and Best Vaccine Site.
Galen Data provides a configurable, scalable, and easy to use software platform allowing medical devices to centralize data and leverage cloud technologies. The Galen Cloud platform collects and securely stores data as well as provides tools to visualize and analyze both patient and device data. Galen Data maintains and secures the Galen Cloud and ensures FDA and global regulatory compliance. Galen is ISO 13458/HITRUST certified and design and operates as an FDA Class III Medical Device from a software platform perspective.
USI solves property & casualty, employee benefit, personal risk and retirement needs nationwide for over 500,000 clients. They provide committed local service teams to understand the specific needs of their clients and provide a local service experience. Through their USI ONE(r) analytics platform, they can deliver customized solutions with positive economic impact for their clients. Founded in 1994, they now have over $2.5B in revenue and 10,000+ associates across over 200 offices nationwide.
Phage Refinery seeks to become a leading service provider of isolation, characterization, purification, and directed evolution of bacteriophages for application in human, animal and plant therapies and diagnostics. Their service platform is flexible and scalable from research to industrial volumes of both feedstock and refined output. Their protected technologies seek to perform requests quickly and efficiently.