ICSR Case Management
End-to-end Individual Case Safety Report processing support to help ensure complete, accurate, medically reviewed, and timely safety reporting.
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Our Services
Pharmacovigilance Services
End-to-end pharmacovigilance and drug-safety support across the product lifecycle to help organizations manage safety information, regulatory obligations, and patient-risk monitoring.
Overview
Pharmacovigilance is essential for identifying, evaluating, understanding, and preventing adverse effects and other safety-related problems associated with medicinal products.
Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, healthcare organizations, and other life-sciences stakeholders with structured pharmacovigilance services covering ICSR processing, safety database activities, literature monitoring, signal management, aggregate reporting, risk management, safety agreements, PSMF support, SOP development, quality compliance, and PV training.
Our approach combines regulatory requirements, medical and scientific review, quality systems, safety-data management, documentation, and lifecycle oversight to help clients establish and maintain effective pharmacovigilance operations.
Our Pharmacovigilance Services Services
Safety Database Management
Reliable safety database support to help ensure accurate case capture, controlled workflows, compliant reporting, traceable changes, and secure management of pharmacovigilance data.
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Signal Management
Structured signal detection, assessment, prioritization, and tracking support to help identify and evaluate emerging product-safety information.
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Literature Monitoring
Structured literature surveillance to identify reportable safety information, emerging risks, and relevant scientific evidence for ongoing pharmacovigilance activities.
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Aggregate Reporting
Structured aggregate safety reporting support to help organizations evaluate cumulative safety data, emerging risks, and the evolving benefit-risk profile of medicinal products.
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Risk Management
Structured pharmacovigilance risk-management support to identify, characterize, monitor, minimize, and communicate important product-safety risks throughout the product lifecycle.
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PV SOP Development
Practical, role-based pharmacovigilance SOP development to help organizations standardize safety activities, define responsibilities, and maintain consistent regulatory compliance.
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PV Training
Practical, role-based pharmacovigilance training designed to strengthen safety knowledge, operational consistency, regulatory awareness, and compliance across PV teams and stakeholders.
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SDEA/PVA Management
Structured safety agreement support to clearly define pharmacovigilance responsibilities, safety-data exchange requirements, timelines, and oversight between business partners.
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PSMF Support
Structured Pharmacovigilance System Master File support to help organizations document, maintain, and demonstrate the operation and oversight of their pharmacovigilance system.
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PV Quality & Compliance
Quality-system and compliance support to help organizations maintain controlled, consistent, traceable, and inspection-ready pharmacovigilance operations.
Explore Service →Key Pharmacovigilance Activities We Support
Depending on scope, MGS can support:- Adverse event intake
- Validity assessment
- Duplicate search
- Seriousness assessment
- Expectedness / listedness assessment
- Causality assessment
- MedDRA coding
- Drug coding
- Narrative preparation
- Medical review
- Follow-up activities
- Expedited reporting
- Periodic reporting
- Case reconciliation
- Literature review
- Signal tracking
- Benefit-risk review support
- Safety database activities
- PV agreements
- PSMF maintenance
- SOP development
- PV training
- Quality review
- Regulatory inspection readiness
Our Pharmacovigilance Approach
- Understand
- Define Responsibilities
- Process & Evaluate
- Report
- Monitor
- Maintain & Improve
Key PV Compliance Considerations
MGS supports clients in addressing areas such as:- Case validity
- Regulatory reporting timelines
- Data quality
- Medical review
- Seriousness
- Expectedness
- Causality
- Coding consistency
- Duplicate management
- Follow-up
- Literature monitoring
- Signal detection
- Aggregate reporting
- Risk management
- Safety-data exchange
- Reconciliation
- Quality oversight
- Training
- Documentation
- Inspection readiness
- Data integrity
- Record retention
Typical PV Deliverables
Depending on the engagement, MGS can provide:- Processed ICSRs
- Case-quality review
- Medical-review support
- Regulatory submission files
- Safety database support
- Literature-search logs
- Literature assessment records
- Signal-tracking documentation
- Signal assessment reports
- Aggregate safety reports
- Risk-management documentation
- SDEAs / PVAs
- PSMF documentation
- PV SOPs and work instructions
- Training materials
- Compliance trackers
- Reconciliation records
- Quality and inspection-readiness support
What Sets MGS Apart
End-to-End PV Support
MGS can support multiple pharmacovigilance functions within a coordinated operating model.Quality-Focused Case Management
Our approach emphasizes complete, consistent, medically reviewed, and traceable safety documentation.Regulatory Awareness
PV activities are structured with consideration of applicable national and international reporting and pharmacovigilance requirements.Flexible Operating Model
Support can be tailored to individual activities, selected processes, or broader PV-system requirements.Documentation & Quality Integration
MGS integrates case processing, SOPs, quality systems, agreements, training, and compliance support.Lifecycle Perspective
Our support can extend from product introduction through routine post-marketing safety surveillance and ongoing system maintenance.Who We Support
MGS can provide pharmacovigilance support for:- Marketing Authorization Holders
- Pharmaceutical companies
- Biopharmaceutical companies
- Generic-drug manufacturers
- CROs
- Healthcare organizations
- Product-license partners
- Distributors and commercial partners with PV responsibilities
- Organizations establishing new PV systems
- Companies expanding or remediating existing PV operations
Protect Patients. Strengthen Safety Systems.
An effective pharmacovigilance system helps organizations identify safety risks early, meet reporting obligations, maintain reliable safety records, and support informed benefit-risk evaluation throughout the product lifecycle.
Partner with MGS for practical, quality-focused, and lifecycle-based Pharmacovigilance support.