Our Comprehensive Services

SafePhV is an innovative cloud-based software designed to manage adverse events and ensure compliance with global pharmacovigilance regulations. It streamlines pharmacovigilance processes, increasing efficiency, speeding up time-to-market, and reducing costs. The platform is fully configurable and adaptable to unique pharmacovigilance requirements and existing IT ecosystems. Developed by Topia Pharma Intelligence, SafePhV leverages AI-driven analytics for proactive drug safety management and global monitoring, featuring an integrated, user-friendly PV database that ensures compliance and efficient data handling.

Sub Services

Tailored Pharmacovigilance Solutions: Streamlined adverse event management, regulatory compliance, AI-driven analytics, and seamless IT integration.

AI/ML & NLP Services

Harness the power of artificial intelligence, machine learning, and natural language processing to automate repetitive tasks, uncover insights from unstructured data, and enable intelligent decision-making across pharmacovigilance operations.

Automated Case Intake

Streamline intake by automatically extracting, validating, and structuring case data from XML and Literature. Reduce manual intervention while ensuring accuracy and faster case turnaround.

Case Processing

Enhance operational efficiency with automated workflows for case triage (NLP-based), data entry, follow-ups, and regulatory submission preparation — enabling higher throughput with fewer errors.

MedDRA Medical Coding

Automated MedDRA medical coding with high accuracy. Ensure consistency, minimize discrepancies, and maintain compliance with regulatory guidelines.

Dynamic Auto Labelling

Simplify safety labelling management with automated updates, version control, and regulatory alignment. Guarantee timely updates of product information across geographies.

Monitoring & Notifications

Enable proactive risk management with real-time monitoring of case activities and system performance. Configurable notifications ensure that stakeholders are always informed of critical developments.

Auto Narratives & Medical Review

Generate regulatory-compliant narratives with AI-driven summarization, while supporting medical reviewers with decision-ready case views to improve productivity and clinical oversight.

Regulatory Reports & e-Submission

Automate the preparation, validation, and secure submission of ICSR, PSUR, and other global regulatory reports. Ensure readiness for audits and reduce compliance risks.

Interactive Reports & Dashboard

Visualize trends, KPIs, and compliance metrics with dynamic dashboards. Drive data-driven decisions with interactive, drill-down reporting tailored to business needs.

ICSR & PSR E2B R2 & R3

Stay compliant with the latest international reporting standards. Seamless generation and submission of E2B R2/R3-compliant reports, ensuring regulatory acceptance globally.

Signal Detection

Identify potential safety signals early with advanced statistical models and AI-driven analytics. Support proactive risk evaluation before escalation.

Regulatory Compliance

Ensure end-to-end adherence to international standards (21 CFR Part 11, ANNEX 11, GDPR, GXP, GAMP5). Built-in controls for audit trails, data integrity, and system validation keep processes secure, compliant, and inspection-ready.

Global and Local Literature review

Leveraging advanced AI/ NLP, we streamline literature screening by intelligently identifying product mentions, adverse events, and important events, reducing manual effort while enhancing accuracy and consistency.

Regulatory Intelligence

AI/NLP-powered monitoring and analysis of global regulatory updates, safety communications, and guideline changes to ensure proactive compliance and informed decision-making.