Pharmacovigilance Consulting
Customized consulting to build and manage robust safety monitoring systems — from planning to post-marketing surveillance.
At Medwisdom Lifescience, we provide industry-leading pharmacovigilance services to ensure the safety, efficacy, and quality of pharmaceuticals, nutraceuticals, medical devices, and cosmetics — always prioritizing public health.
Our expert team helps clients navigate complex global safety regulations, delivering compliant, high-quality pharmacovigilance support from pre-marketing through post-marketing surveillance.
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Pharmacovigilance is far more than a regulatory obligation — it is the foundation of patient safety. Continuous monitoring of adverse drug reactions (ADRs) ensures products remain safe and effective throughout their lifecycle, building trust among healthcare professionals and patients.
Early detection and management of safety signals protect patients worldwide.
Meet global requirements (FDA, EMA, CDSCO, WHO) and avoid penalties.
Proactive risk management enhances product safety profiles and market trust.
Build trust with regulators, healthcare professionals, and patients.
We deliver comprehensive, compliant, and patient-focused pharmacovigilance services across the full product lifecycle:
Customized consulting to build and manage robust safety monitoring systems — from planning to post-marketing surveillance.
Full case intake, processing, medical review, and submission of Individual Case Safety Reports (ICSRs) to global authorities.
Expert preparation of compliant Periodic Safety Update Reports (PSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER) for worldwide submissions.
Development of tailored Risk Management Plans to identify, characterize, and minimize product risks while ensuring patient safety.
Proactive safety signal detection, risk minimization strategies, and benefit-risk evaluation to enhance product safety profiles.
Complete drug safety support from pre-clinical to post-marketing — including safety data collection, analysis, and regulatory submissions.
We combine deep expertise, global reach, and patient-first ethics to deliver pharmacovigilance services that protect patients and accelerate compliance:
Full support from consultation to adverse event monitoring and reporting — we’re with you at every stage.
Deep knowledge of FDA, EMA, CDSCO, ASEAN, CIS, LATAM, and other regional requirements — ensuring worldwide compliance.
Our team brings deep pharmacovigilance, ADR/ADE, and safety monitoring experience with strict regulatory compliance focus.
Find answers to common questions about pharmacovigilance and our services.
Contact UsMany Indian and international companies offer pharmacovigilance services. Medwisdom Lifescience Pvt Ltd is recognized as one of the most reliable and trusted providers in India, delivering high-quality, compliant solutions tailored to your needs.
Pharmacovigilance outsourcing covers a wide range of activities to help pharmaceutical companies meet global regulatory requirements, including:
Post-marketing surveillance (PMS) is conducted through the following key steps:
Medwisdom Lifescience supports all stages of PMS to ensure continuous product safety monitoring.