Ablenio provides comprehensive regulatory support for biologics application. We guide clients through India’s end-to-end approval process, from regulatory strategy and dossier preparation to DCGI/CDSCO submissions and post-approval maintenance. We help teams identify the correct Indian regulatory pathway, prepare highly compliant dossiers, submit through SUGAM, and manage clarifications throughout the review cycle. Whether you’re planning a first-in-India filing or maintaining an approved product, our support adds structure and predictability at every stage.
We also support manufacturing and import licensing, state-level drug licensing, and site approvals. Our India-focused expertise ensures that every submission aligns with both written guidelines and practical regulatory expectations.
At Ablenio, our regulatory process emphasizes clarity, accuracy, and proactive planning. We begin with a detailed review of your product and data package to assess regulatory readiness and determine the most efficient approval route. We outline timelines, documentation needs, and anticipated authority questions early in the process, reducing avoidable delays. Throughout dossier development, we maintain close coordination with your scientific and clinical teams to ensure every module meets Indian regulatory standards. Once a submission is filed, we track its status, manage clarifications promptly, and maintain continuous communication with DCGI/CDSCO until review is complete.
NovelMed Therapeutics is a biotechnology company that conducts cutting-edge therapeutics research and development for complement-mediated diseases.
