Ensure Drug Safety with Advanced Detection and Compliance
At Indivirtus Healthcare Services Pvt. Ltd., our Signal Management services provide end-to-end solutions for pharmaceutical and biotech companies. Using tools like Empirica and VigiLyze, we deliver early detection, validation, and regulatory handling of adverse drug reactions, ensuring safety signal integrity and global pharmacovigilance compliance.
Our services encompass advanced disproportionality analysis, signal detection, validation, and regulatory communication using tools like Empirica and VigiLyze, ensuring pharmacovigilance compliance and drug safety.
Effective signal management ensures patient safety, regulatory compliance, and timely identification of adverse drug reactions, supporting audit readiness and global market approvals.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led pharmacovigilance solutions, providing accurate, compliant signal detection and regulatory support for pharmaceutical safety.
At Indivirtus Healthcare Services, our Signal Management services are led by certified pharmacovigilance experts specializing in global drug safety. We utilize advanced tools like Empirica and VigiLyze for disproportionality analysis, perform structured signal validation, and manage regulatory communications to ensure compliance.
Our tailored approach integrates robust data analysis with regulatory expertise, delivering audit-ready signal management solutions that align with global pharmacovigilance standards and support patient safety.
Signal Detection Report: Comprehensive analysis of adverse drug reaction signals.
Validated Signal Assessment Dossier: Detailed evaluation of detected signals.
Tool-Based Analysis (Empirica, VigiLyze): Advanced data-driven insights.
Regulatory Communication Drafts/Responses: Compliant submissions for authorities.
Our Signal Management services align with stringent global pharmacovigilance standards, ensuring your documentation is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance safety and regulatory confidence.
Our Signal Management services are essential for pharmaceutical and biotech companies ensuring drug safety and compliance. Ideal for adverse event monitoring, regulatory reporting, and audit preparation, our solutions support global pharmacovigilance requirements. Key use cases include detecting signals for new drugs, managing post-market surveillance, and ensuring compliance for global market approvals.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical and biotech companies, delivering expert-led signal management solutions backed by certified pharmacovigilance experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, accurate, and robust signal management, driving regulatory success and patient safety.
Signal management involves identifying, validating, and assessing potential safety signals from pharmacovigilance data to ensure timely regulatory actions and patient safety.
Disproportionality analysis uses statistical algorithms to detect unusual reporting patterns, helping identify potential safety concerns earlier than traditional methods.
We use industry-standard tools like Oracle Empirica Signal and WHO VigiLyze to detect, monitor, and track safety signals from global safety databases.
We assist in preparing and submitting regulatory documentation related to validated safety signals, including PSUR addendums, DSUR updates, and direct responses to agency inquiries.
Yes, signal management services can be availed independently or as part of a full pharmacovigilance suite, based on your organization’s needs.
Our services include signal detection, validation, disproportionality analysis using Empirica and VigiLyze, and regulatory communication, ensuring pharmacovigilance compliance.
Pharmaceutical and biotech companies monitoring adverse drug reactions, ensuring drug safety, or preparing for regulatory audits benefit from our tailored solutions.
Our services align with ICH E2E, EMA GVP Module IX, FDA Guidance, and WHO Pharmacovigilance Guidelines, ensuring compliance with global standards.
Clients receive signal detection reports, validated signal assessment dossiers, tool-based analysis (Empirica, VigiLyze), and regulatory communication drafts/responses.
Yes, our services are tailored to your specific drug products, safety monitoring needs, and regulatory requirements, ensuring compliant and effective solutions.
We use advanced tools like Empirica and VigiLyze for disproportionality analysis and structured validation, ensuring early detection and regulatory reporting of adverse events.