The company was established to provide comprehensive solution to Medical Devices Israeli early-stage and incubator-based companies, navigating the dynamic areas of product development and regulatory strategy.
We have knowledge and contemporary experience with regulatory pathways and can provide the requisite preclinical, clinical, quality, manufacturing support to increase your chances for success.
The company has escorted companies from the concept stage to market entry,
supporting both FDA and CE mark approvals along with the preclinical or clinical
studies required for the process.
We have provided our services to various companies in diverse fields, including
cardiology, dermatology, urology ophthalmology, OBYGN, gastroenterology, cell
therapy, medical cannabis and others.
The company has a unique approach in support emerging technologies. Instead of
external regulatory support, team members of the company are involved in every stem of R&D, testing and production, allowing to shorten the regulatory pathway.
Miri Sani, the company CEO has more than 25 years of experience in the Israeli
Biotech industry and has worked in several companies as VP of regulatory affairs. As part of her responsibilities, Ms. Sani has designed and conducted many clinical
studies worldwide. She also led vast process of FDA and CE mark approvals. Ms.
Sani served as VP of Regulatory Affairs in Notal Vision that developed solutions for
the early detection and monitoring of Age-Related Macular Degeneration (AMD),
ConTipi that provided female urine incontinence solutions, and MTRE that developed a thermoregulation system for surgeries.
Ms. Sani, has vast experience in designing, conducting and monitoring of preclinical and clinical studies which were utilized in successful FDA and CE Mark submissions.