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Zelthy-Regulatory Compliance Reporting

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What is this product? Zelthy Regulatory Compliance Reporting is an application for pharmaceutical companies managing traceability reporting obligations across multiple jurisdictions. It automates the preparation and submission of compliance reports per jurisdiction-specific requirements — DSCSA (US), EU FMD (Europe), India DCTS, and other emerging market regulations — with pre-submission validation and exception management to prevent submission failures. Key Features & Functionalities - Multi-market regulatory reporting (DSCSA, EU FMD, India DCTS, and more) - Automated report generation per jurisdiction requirements - Pre-submission validation with error detection - Exception management and remediation workflows - Audit trail for all submissions and corrections Primary Solution & Value Pharmaceutical companies operating across markets face different traceability reporting requirements in each jurisdiction — with different formats, submission timelines, and compliance standards. Manual report preparation across multiple regulatory bodies is error-prone and time-consuming. This application automates multi-market reporting from a single traceability data set, reducing compliance risk and submission errors.

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