End-to-End Pharmacovigilance Solutions

We provide comprehensive Pharmacovigilance Services to ensure patient safety and compliance with global and local regulations. Our pharmacovigilance team can set up and maintain your drug safety system, manage safety data, and fulfil all reporting obligations to regulators.

We offer end-to-end expertise in Pharmacovigilance and Regulatory Compliance, supporting pharmaceutical and biotech companies in upholding the highest standards of patient safety across the entire product lifecycle

Based in Singapore, we serve clients across Asia-Pacific and beyond, providing deep understanding of local regulatory requirements while maintaining global compliance standards.

Our Pharmacovigilance Services

Comprehensive drug safety solutions designed to protect patients and ensure regulatory compliance

PV System Setup & Maintenance

Establishment of robust pharmacovigilance systems and ongoing maintenance to meet evolving regulatory requirements. We ensure your PV system remains compliant and audit-ready.

Global Regulatory Compliance

Ensuring adherence to global and regional pharmacovigilance guidelines (FDA, EMA, ICH) as well as country-specific requirements in Asia-Pacific and Beyond.

Case Processing & Reporting

End-to-end management of adverse event case processing, including intake, assessment, and submission of Individual Case Safety Reports (ICSRs), PBRER/PSUR, and DSUR preparation.

Signal Detection & Risk Management

Continuous monitoring of safety data to detect signals of potential adverse effects, and implementation of risk management strategies to mitigate identified risks.

Risk Management Plans (RMPs)

Preparation, review, Submission and distribution of RMPs in compliance with regulatory requirements, including maintenance of distribution records to ensure traceability and audit readiness.

Literature Screening & Analysis

Regular screening of scientific and medical literature for relevant safety information, and analysis of any identified case reports or safety signals in literature sources.

Safety Consulting for Programs

Pharmacovigilance support for organized data collection programs such as Patient Support Programs (PSPs), Market Research Programs (MRPs), and Digital Assets (DAs).

Training & SOP Development

Provision of pharmacovigilance training for your staff and development of Standard Operating Procedures (SOPs) tailored to your processes, promoting compliance and consistency.

Post-Marketing Surveillance

Design and implementation of post-marketing safety surveillance activities and observational studies to monitor product safety in real-world settings.

Pharmacovigilance System Master File

Preparation and maintenance of the PSMF, a comprehensive document that records your PV system details, ensuring it remains up-to-date and audit-ready.

Safety Data Exchange Agreements

Drafting and review of SDEAs to formally outline safety data exchange responsibilities between partners or affiliates, in compliance with regulatory expectations.

Audit & Inspection Support

Assistance with pharmacovigilance audits and health authority inspections, including pre-audit gap analyses and preparation of required documentation

Why Choose iPharmX for Pharmacovigilance?

Expert drug safety solutions with proven regulatory compliance track record

Regulatory Expertise

Deep knowledge of global and regional PV regulations including FDA, EMA, ICH guidelines, and Asia-Pacific specific requirements.

Timely Compliance

Efficient case processing and reporting to meet regulatory timelines, ensuring your organization remains compliant with all submission deadlines.

Quality Assurance

We follow a comprehensive quality management system that emphasizes inspection and audit readiness, along with strong documentation practices. Our structured approach ensures data integrity, ongoing audit preparedness, and consistent regulatory compliance.

Ready to Enhance Your Drug Safety Program?

Contact us to discuss how our pharmacovigilance services can support your patient safety goals and regulatory compliance requirements.

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