Elexes

Founded by a team of professionals with over 20 years of experience, Elexes is dedicated towards bringing safe and effective healthcare products to the market and ensuring that the existing ones are in compliance. We comprise of professionals who are RAC certified by RAPS, Certified Quality Auditor by American Society of Quality, and Certified Lead Auditors for ISO 13485, cGMP, 14971, and 9001. Specializing in Medical Devices, IVD, Combination Products, Biologics and Drugs, we have developed into a trusted online partner offering a wide range of compliance and market-access services, with an expertise in regulatory submissions, post market surveillance, product documentation, clinical writing and quality systems. Over the past years, we have served more than 50 clients, both national and international, assisted with several FDA submissions, CE marks, NDA, IND, BLA, 510k, and offered numerous other regulatory and quality services. Get in touch with us and we can address your requirements pertaining to the US, EU, Canada and markets all around the world. Let's work together and give the best to the society!