Empowering India & Global Healthcare Through
Regulatory Excellence & Clinical Research Expertise
We help Pharma, Med-Tech, Biotech, Food and IVD companies bring safe, compliant, and innovative products to global markets — faster, ethically, and confidently.
About Company Section
Your trusted partner for regulatory excellence and clinical success
“CliniExperts established in 2009 form a unified, global powerhouse offering end-to-end regulatory consulting, clinical research, and market access solutions for pharmaceuticals, biologics, medical devices, and in-vitro diagnostics. For over a decade, we have helped healthcare innovators navigate complex regulatory frameworks, conduct globally compliant clinical investigations, and secure approvals from major health authorities including US FDA, EMA, MHRA, and CDSCO.
Built on scientific integrity, regulatory depth, and operational excellence, our mission is simple: To accelerate safe, ethical, and compliant product launches worldwide.”
Global Presence & Regulatory Reach
Our Global presence and Regulatory reach showing our international relevance
We Operate Across:
USA
US FDA (CDER, CEBER, ORA) regulatory filings, agent-of-record servicesIndia
US FDA (CDER, CEBER, ORA) regulatory filings, agent-of-record servicesUK & Europe
US FDA (CDER, CEBER, ORA) regulatory filings, agent-of-record servicesUSA
US FDA (CDER, CEBER, ORA) regulatory filings, agent-of-record servicesIndia
US FDA (CDER, CEBER, ORA) regulatory filings, agent-of-record servicesUK & Europe
US FDA (CDER, CEBER, ORA) regulatory filings, agent-of-record services
Meet The Experts Behind Your Success
The strength of CliniExperts International lies in our people.
Our multidisciplinary team brings together regulatory scientists, clinical project managers, biostatisticians, medical writers, and strategic advisors—each with deep expertise in their respective domains and a shared commitment to your success.
Dr. Ashwini Kumar, AIIMS alumnus and India’s top clinical research expert, founded CliniExperts to simplify global regulatory processes. With deep regulatory and pharma expertise, CliniExperts is a trusted partner across global markets.
Rashmi Verma, COO at CliniExperts and HBTI Kanpur alumna, drives innovation across IT, policy, and operations. She leads scalable strategies enabling business growth across international markets.