We provide comprehensive Pharmacovigilance (PV) services to ensure the safety and efficacy of pharmaceutical products throughout their lifecycle. Our solutions are designed to help pharmaceutical companies comply with global regulatory requirements, mitigate risks, and protect patient health.
Our Pharmacovigilance Services Include:
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Adverse Event (AE) Reporting & Management
Timely collection, assessment, and submission of Individual Case Safety Reports (ICSRs) in accordance with international regulations. -
Signal Detection & Risk Management
Continuous monitoring for safety signals and implementation of risk minimization strategies to support product safety profiles. -
Literature Surveillance
Regular screening of scientific and medical literature for adverse events and safety updates related to client products. -
Aggregate Reporting
Preparation of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). -
Medical Review & Quality Assurance
In-depth medical evaluation of safety data and implementation of robust QA processes to ensure accuracy and compliance. -
Regulatory Submissions
End-to-end support for submission of safety data to global health authorities, including FDA, EMA, MHRA, and others.