SMO India Clinical Research Pvt. Ltd. is a Bengaluru-based regulatory and clinical research organization supporting medical device, pharmaceutical, and biotech companies across India and global markets.
Regulatory Affairs & Medical Devices
SMO India operates a dedicated regulatory affairs vertical working across FDA, CDSCO, and MHRA frameworks. We are India’s first FDA-recognized Third-Party 510(k) Review Unit, authorized to conduct independent third-party reviews for eligible medical devices under the FDA’s Third-Party Review Program.
This function operates under strict conflict-of-interest controls and is fully segregated from consulting and CRO activities. Our role is evaluative—not advisory—focused on regulatory readiness audits, evidence quality assessment, and FDA-aligned review processes that withstand direct regulatory oversight.
Clinical Research Services
Alongside regulatory operations, SMO India is a full-service CRO with over a decade of experience supporting clinical trial execution across India. Our capabilities include site management and patient recruitment, protocol development and ethics submissions, regulatory documentation, and real-world evidence and post-marketing surveillance.
With deep subject-matter expertise and globally aligned quality systems, we help organizations de-risk development, strengthen compliance, and achieve credible, scalable market access.
📬 For partnerships and collaborations: info@smo-india.com

SMO India

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