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New Salt Addition Process & Compliance Governance
- •Identified the absence of standardised controls around the addition of new drug salts to the platform and led the design of a structured SOP governing the entire process.
- •The framework ensured that every new salt added to the system had verified CDSCO approval, mapped indications, and passed mandatory compliance checks.
- •Collaborated with the catalog, compliance, medical affairs, and backend teams to embed the process into existing workflows.
The Challenge
- Without a standardised process, new salt additions were being handled inconsistently — creating compliance risk at the point of first entry into the system.
- Coordinating approval verification against CDSCO's database for every request required a scalable workflow, not a manual check.
The Approach
- Designed a step-by-step SOP for salt addition, with CDSCO approval as a mandatory first-gate check.
- Embedded indication mapping and compliance attribute completion as required fields before a salt could be marked live.
- Revised and documented the SOP in collaboration with the catalog and compliance teams.
Results
100% of new salt additions passing through the CDSCO-verified process post-implementation.
Indication mapping and compliance attribute coverage standardised across all new additions.
Salt addition request handling: 75-84 requests per quarter processed with consistent SOP compliance.
Tech Stack
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