Smo India

SMO India Clinical Research Pvt Ltd is a Bangalore-based full-service clinical research organization (CRO) with over a decade of experience supporting pharmaceutical, biotech, and medical device companies across India and globally. We specialize in: Clinical trial site management & patient recruitment Regulatory affairs strategy and documentation Protocol development and ethics submissions Real-world evidence and post-marketing surveillance Regulatory Affairs & 510(k) Device Review SMO India is now expanding into regulatory consulting for medical device manufacturers targeting the U.S. market. We're currently in the process of applying for FDA accreditation as a Third Party Reviewer under the 510(k) program (3P510k). Led by a U.S-trained team with FDA project experience, we aim to: Help manufacturers navigate complex regulatory pathways Deliver compliance-focused technical assessments Support global quality standards while operating cost-efficiently from India With a presence in both India and the U.S, our goal is to bridge regulatory expectations with on-ground manufacturing capability — responsibly, transparently, and with deep subject matter expertise. For partnership or collaboration inquiries: info@smo-india.com