We assist in the preparation of your Plant Master File (PMF) and Device Master File (DMF) in accordance with the Indian Medical Device Rules (MDR) and global market requirements, ensuring your product documentation is comprehensive and compliant.

Obtain the necessary wholesale distribution licenses for your pharmaceutical or medical device products in India, ensuring compliance with local regulations.

We help you navigate the regulatory landscape to obtain the import license needed for importing drugs or medical devices into India, complying with Indian Drug and Cosmetics Act.

Obtaining a license for manufacturing Class A and B (MD-5) or Class C and D (MD-9) medical devices is a key regulatory requirement in India. This license ensures compliance with safety and quality standards, enabling legal production and distribution while demonstrating adherence to India's medical device regulations and commitment to public health.

Our Training and Education services are crafted to equip clients and their teams with the expertise and skills required to excel in the intricate domains of regulatory compliance, quality assurance, clinical trials and medical device Trainings with Complete Training Frameworks, Adapted to Suit Client Specifications, Accreditations and Certifications.

The Central Drugs Standard Control Organization (CDSCO) is India’s National Regulatory Authority (NRA) for cosmetics, pharmaceuticals, and medical devices. It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare. To ensure safety, the Indian government has mandated CDSCO regulation for medical devices, cosmetics, and contraceptives. CDSCO approves product quality and issues licenses for critical drugs, including blood products, vaccines, injections, medical devices, and sera.