ComplianceProduct StrategyRegulatoryProcess Design

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.

New Salt Addition Process & Compliance Governance

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 & Solution

  • 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.

Key Results & Commercial Impact

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.

Technology Stack & Tools

CMSExcelConfluenceGoogle Workspace
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