As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in…
The COVID-19 pandemic has transformed the worldwide regulator performing on approval of medicine as a fast-track process and involved in mutual accord in bringing a drug of importance for the civic. This is a major challenge as the safety and…
What is SaMD? Software as Medical Device, or SaMD, can be described as “a class of medical software designed to carry out one or more medical functions without the need for actual hardware. This can comprise of software or applications…
Introduction When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible. While IND application sponsors are not required to submit information regarding clinical investigators’…
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ProRelix Research is the rapidly growing Contract/ Clinical Research Organization (CRO) with multi-country service capability supporting phase 1, 2, 3, & 4 clinical trials of Pharma, Biotech, Biopharma, Medical Device, Nutraceutical & Herbal companies to conduct in the USA, India, Europe & South East Asia.