Tell us about your product, market, and timeline — our specialists will design a testing programme that fits.
Our scientific team will help you identify the right tests, methods, and accreditations for your product or sample.
From adverse event intake to electronic regulatory submission — complete Individual Case Safety Report management handled by our trained drug safety team.
Understanding ICSRs
An Individual Case Safety Report (ICSR) is the cornerstone of pharmacovigilance. It is a structured report that captures all relevant information about a single adverse event associated with a medicinal product — including patient demographics, drug details, event description, clinical outcome, and causality assessment.
ICSRs are submitted by Marketing Authorization Holders to national regulators (CDSCO/PvPI in India), and to international regulators such as EMA, FDA and MHRA.
Regulatory Basis (India): NDCT Rules 2019, Rule 37 mandates all MAHs to report serious adverse events (SAEs) within 15 calendar days and all non-serious adverse events within 90 calendar days to CDSCO/PvPI. Fatal or life-threatening SUSARs must be reported within 7 days.
Our Services
We receive adverse event reports from all sources — spontaneous reports, clinical trials, literature, company-sponsored studies, consumer reports, and health authority-mandated surveillance programmes.
Each case is assessed for seriousness, expectedness and completeness. Duplicate case identification is performed using patient demographics, product and event matching algorithms before data entry.
Our MedDRA-licensed team codes all adverse event terms and indications using the MedDRA dictionary, correctly mapping at LLT, PT, HLT, HLGT and SOC levels as required.
Medical review by experienced safety physicians applying WHO-UMC and Naranjo causality criteria. Labelling assessment against reference documents (SmPC, IB, SPL).
Generation of ICH E2B(R3)-compliant XML files for electronic submission. Direct AS2/gateway transmission to EMA (EudraVigilance), US FDA (MedWatch/FAERS), MHRA and PvPI/CDSCO.
Structured follow-up queries sent to reporters. All follow-up information incorporated, with versioned reports reflecting updates to the case record.
Regulatory Timelines
| ICSR Type | India (CDSCO) | EU (EMA) | US (FDA) |
|---|---|---|---|
| Fatal / Life-threatening SUSAR | 7 Cal. Days | 7 Cal. Days | 7 Cal. Days |
| Non-fatal / Non-LT SUSAR | 15 Calendar Days | 15 Calendar Days | 15 Calendar Days |
| Serious AE (post-marketing) | 15 Calendar Days | 15 Calendar Days | 15 Calendar Days |
| Non-serious AE (post-marketing) | 90 Calendar Days | 90 Calendar Days | 90 Calendar Days |
Common Questions
Contact our PV team for a free consultation on ICSR case processing and electronic regulatory submission.
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