The importation of biological products requires meticulous attention to ensure their safety and efficacy. The CDSCO is responsible for overseeing and granting approval for the import of biological. The import procedure involves several steps, similar to manufacturing permission, including registration certificate, obtaining an import license, securing market authorization, and acquiring clinical trial permissions. At FDA RAQA Solutions, our team of experts, skilled in regulatory writing, provides comprehensive, end-to-end services to ensure a seamless and efficient process for our clients.