MediReg Solutions India is a comprehensive regulatory consulting partner that helps healthcare and life science companies achieve compliance, secure approvals, and enter markets faster. With deep regulatory expertise and a strong track record, we support the entire product lifecycle—from strategy and documentation to certification and post market compliance.
646, Varun Enclave, Sector 28, Noida, UP-201301.
Complete assistance for CDSCO approvals, ensuring smooth and compliant product entry into the Indian market.
End-to-end support for import licensing of medical devices, pharma, and healthcare products.
Establish quality management systems to meet global standards for medical device manufacturing.
Preparation of technical files, design dossiers, and clinical evaluation reports for regulatory submissions.
Guidance for BIS certification and WPC ETA approvals for regulated electronic and medical devices.
Regulatory guidance and documentation for AI/ML-based medical software and digital health products.
Complete regulatory services for pharmaceutical products including submissions and compliance.
Ongoing regulatory compliance, renewals, and support to maintain approvals and business continuity.