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Pharmacovigilance

End-to-End Pharmacovigilance Solutions

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 Services

Importance of Pharmacovigilance

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.

Patient Safety First

Early detection and management of safety signals protect patients worldwide.

Regulatory Compliance

Meet global requirements (FDA, EMA, CDSCO, WHO) and avoid penalties.

Risk Minimization

Proactive risk management enhances product safety profiles and market trust.

Stakeholder Confidence

Build trust with regulators, healthcare professionals, and patients.

Our Pharmacovigilance Solutions

We deliver comprehensive, compliant, and patient-focused pharmacovigilance services across the full product lifecycle:

Pharmacovigilance Consulting

Customized consulting to build and manage robust safety monitoring systems — from planning to post-marketing surveillance.

Case Processing & ICSR

Full case intake, processing, medical review, and submission of Individual Case Safety Reports (ICSRs) to global authorities.

PSUR / PBRER Preparation

Expert preparation of compliant Periodic Safety Update Reports (PSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER) for worldwide submissions.

Risk Management Plan (RMP)

Development of tailored Risk Management Plans to identify, characterize, and minimize product risks while ensuring patient safety.

Pharmacovigilance Risk Management

Proactive safety signal detection, risk minimization strategies, and benefit-risk evaluation to enhance product safety profiles.

Full Drug Safety Services

Complete drug safety support from pre-clinical to post-marketing — including safety data collection, analysis, and regulatory submissions.

Why Choose Medwisdom Lifescience For Pharmacovigilance?

We combine deep expertise, global reach, and patient-first ethics to deliver pharmacovigilance services that protect patients and accelerate compliance:

Step-by-Step Guidance

Full support from consultation to adverse event monitoring and reporting — we’re with you at every stage.

Global Regulatory Expertise

Deep knowledge of FDA, EMA, CDSCO, ASEAN, CIS, LATAM, and other regional requirements — ensuring worldwide compliance.

Industry-Leading Experts

Our team brings deep pharmacovigilance, ADR/ADE, and safety monitoring experience with strict regulatory compliance focus.

FAQs

Frequently Asked Questions

Find answers to common questions about pharmacovigilance and our services.

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Many 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:

  • Case intake, processing, and ICSR management
  • Risk Management Plan (RMP) development
  • Periodic Safety Update Report (PSUR) preparation
  • Adverse event / ADR reporting
  • Signal detection and risk minimization
  • Training, audit preparation, and compliance support

Post-marketing surveillance (PMS) is conducted through the following key steps:

  • Adverse Event / ADR Reporting
  • Patient Registries & Active Surveillance
  • Database Analysis & Signal Detection
  • Risk Minimization Measures
  • Periodic Safety Update Reporting (PSUR/PBRER)
  • Collaboration with Regulatory Authorities

Medwisdom Lifescience supports all stages of PMS to ensure continuous product safety monitoring.