About Us

We are one of the leading Regulatory Consultants specializing in Medical Device and In-Vitro Medical Device Licences for Manufacturing, Import, Test, Sale & Distribute and Loan Licence in India. We provide complete guidance to comply with the obligations of the Medical Device Rule, 2017. We provide complete guidance from registration with CDSCO to getting the license. We coordinate with the concerned department to get the license on time.

We provide regulatory advisory & guidance form layout designing, product development and getting regulatory approvals from India to start a new Pharmaceutical, Cosmetics, Wholesale, AYUSH, Food (FSSAI), and Medical Device Manufacturing Unit.

We assist our clients to establish Quality Management System by providing training, system implementation, and QMS Certifications like ISO 9001, ISO 13485, ISO 14001, HACCP, HALAL, SA 8000 & UK CA, and CE Marking. We guide to classify the device and prepare Technical Files for assessment as per REGULATION (EU) 2017/745 and getting CE Certificate.

We assist our clients to get their Facility Register and annually renew with US FDA. We assist our clients to register the product and get NDC Number from US FDA. We provide guidance to comply with the requirement of 510K Submission.

We assist to comply with the obligations of Unique Device Identification (UDI). We guide to comply with the UDI Requirements of various regulatory authorities like US FDA, EUDAMED, and CDSCO. We provide guidance to get ready the required data to be submitted to Global Unique Device Identification Database (GUDID).