EARE Sets Record for FDA Approvals

               
                Daphne Young
 
      Magister Emanuel A. Rosen, president of EARE Consulting Service first established his company  in the USA. He had worked in Israel during the  early days of the State, but in 1951 he returned to the US to continue his studies, finally returning to Israel in 1974.  He  reactivated his company in 1986 as Israeli company with American style know-how.
     Eilat-based EARE provides GMP and other regulatory services to help Israeli companies meet FDA requirements to market in the US, utilizing licensed professionals or recognized experts in their fields to provide clients with the most up-to-date, comprehensive consultations available at one address.
     “Among the programs and services offered to help raise standards and profitability, the company evaluates plant processes, analyzes standard operating procedures, and explains the complicated regulations of the American FDA regulation system”, explains Rosen.
     EARE also provides other disciplines which may be needed, such as validation for non-clinical  and clinical studies, as well as providing a number of programs designed to improve production.
     Among EAR’s recent successes has been Ramat Yishai-based MEDOC Avanced Medical Systems, manufacturers of computerized neurophysiology medical devices, receiving US FDA approval to market the Vibratory Sensory Analizer – VSA 3000 in the US.
     “This is the second MEDOC device to receive FDA approval, the first being the Thermal Sensory Analyser – TSA-2201”, says Rosen. “We  have established a record for submitting successful applications for the FDA in the shortest possible time. Approval to market VSA-3000 was received 92 days from submission date, which the FDA estimated would take 165 days”.
     The TSA-2001 has been sold and used in leading hospitals and research centres throughout the US. Together with the VSA-3000, the two devices jointly allow the neurologist to make a comprehensive evolution of peripheral neural functioning.
     Another successful “chalk-up” was FDA approval won for Truphatek of Netanya for its laryngoscope; thus enabling the product to enter the US market. Approval was obtained in less than two weeks. “There is no guarantee that the application will be successful”, states Rosen. “What we do is to make sure that the client knows what he has to provide  and what he has to do to gain FDA approval”,
     EARE has made important contributions to the Israeli pharmaceutical and medical device industry over the years, going from strength to strength.