HEALTHCARE REGULATORY COMPLIANCE

Our team has extensive experience in regulatory affairs in pharmaceuticals, biosimilars, and medical devices. We help you navigate through the complex legal and regulatory framework that essentially governs the industry. Our team represents and deals with the regulatory affairs at the Indian drug and medical device regulatory office, CDSCO, as well as various state drug regulatory departments. Our team also has robust experience and knowledge of drug and medical device regulatory requirements in other jurisdictions as well like US, EP, ROW.

We can be your invaluable information resource and services for generic drug, biosimilar, medical device manufacturers and importers, providing insights on new drug applications, subsequent/abbreviated new drug application, import license, clinical trials permissions, medical device registration and license, biosimilar registration and license.

Our services include assistance in regulatory submissions, compliance assessments, clinical trial related submissions, and post-marketing product safety information submission. We also provide legal counsel related to other healthcare laws such as those related to NDPS Act, DPCO, Drugs and Magic Remedies Act, Medicinal and Toilet Preparations Act.