Description

Our CDSCO Licensing Services: What We Do Regulatory assessment & classification Determine whether your product qualifies as a drug, cosmetic, or medical device. For devices, classify it into Class A / B / C / D (risk-based). Gap analysis & roadmap Evaluate the current status of your documentation, quality systems, testing / validation data, labeling, etc. Prepare a tailored roadmap showing the steps and timelines. Dossier & technical documentation preparation Prepare or review technical files, design dossiers, risk analysis, biocompatibility, performance data, stability, etc. Prepare manufacturing site documents (Site Master File, Plant Master File) and QMS documentation. Submission & follow-up File the application in the proper CDSCO / MDR portal (e.g. MD Online, Sugam, etc.). Liaise with CDSCO authorities, respond to queries, attend clarifications or inspections.