Regulatory submissions in India require more than strong scientific expertise. They must be formatted, structured, and validated exactly as DCGI/CDSCO expects. Ablenio provides dedicated publishing and electronic submission support designed specifically for India’s regulatory portals and technical guidelines.
We provide guidance on how to prepare, compile, and quality check all components of your dossier in CTD/eCTD or India-specific formats, ensuring every file is fully compliant and ready for upload. Our team manages the full submission cycle, from assembling administrative documents to validating the structure and overseeing portal uploads on SUGAM.
Our publishing workflow is structured, accurate, and designed to eliminate technical errors before they reach the regulator. We begin by reviewing your documents for completeness and formatting requirements, then assemble the dossier, including labeling, artwork, and module content, into a cohesive submission package.
Before uploading, we validate every file for structure, naming conventions, metadata, and compatibility with Indian portal requirements. Once the dossier is submitted, we monitor its status, manage follow up requests, and maintain all archival versions so future updates can be executed quickly and consistently.
Our experience with Indian submission portals allows us to prevent common submission errors that cause delays, such as technical deficiencies, file incompatibilities, and incomplete metadata. By ensuring that submissions are clean, complete, and regulator ready, we help streamline review timelines and reduce unnecessary clarification cycles.