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Pharmacovigilance services

Pharmacovigilance Services

ICSRs Processing and Submission Literature Management Aggregate Report Management Signal Management Risk Management Plan Pharmacovigilance Audits QPPV service

Ensuring the integrity and effectiveness of your pharmacovigilance practices is essential for maintaining regulatory compliance and safeguarding patient safety. At Navatio Pharma, we offer comprehensive pharmacovigilance audit services designed to assess, enhance, and ensure the quality of your safety monitoring systems.

ICSR Case Processing and Submission

ICSR management at Navatio ensures accurate and cost-effective adverse event reporting with end-to-end compliance and a focus on patient safety.

Literature Surveillance

Literature monitoring involves systematic screening and analysis of scientific publications to detect adverse events and identify safety signals. At Navatio Pharma Solutions, we utilize advanced tools and industry-leading search engines to ensure accurate identification of relevant safety information, supporting regulatory compliance and safeguarding patient health.

Aggregate report Management

At Navatio Pharma Solutions, we specialize in managing the creation and submission of aggregate reports to ensure regulatory compliance and the protection of public health. Our services are tailored to meet the needs of pharmaceutical and biotechnology companies of all sizes.

Here are the examples of Aggregate reports :

Signal Management

Signal management is a key pharmacovigilance process that detects, assesses, and addresses potential safety concerns with medicinal products, ensuring emerging safety signals are identified and evaluated quickly to protect patient safety and meet regulatory standards.

Our Signal Management Process:

Signal Detection

Continuous monitoring of ICSRs, literature, and databases using advanced analytics.

Validation & Confirmation

Expert medical review and cross-validation with global safety databases.

Assessment & Prioritization

Evaluating frequency, severity, and clinical impact with regulatory collaboration.

Signal Communication

Transparent reporting to agencies (EMA, FDA, MHRA) with Benefit-Risk Evaluations.

Regulatory Action & Risk Mitigation

Implementing risk minimization strategies, label updates, and ongoing monitoring.

Risk Management Plan

A Risk Management Plan (RMP) is essential for identifying, assessing, and minimizing risks related to pharmaceutical products. It helps ensure patient safety and regulatory compliance throughout a product's lifecycle by proactively managing potential risks.

Identification

Detecting potential safety concerns

Assessment

Evaluating the severity and impact

Minimization

Implementing strategies to reduce risks

Communication

Transparent reporting to regulatory authorities

Continuous Monitoring

Ongoing evaluation & updates

Pharmacovigilance Audits

Ensuring the integrity and effectiveness of your pharmacovigilance practices is essential for maintaining regulatory compliance and safeguarding patient safety. At Navatio Pharma, we offer comprehensive pharmacovigilance audit services designed to assess, enhance, and ensure the quality of your safety monitoring systems.

Our Pharmacovigilance Audits Services Include

  1. Comprehensive Audits
    In-depth evaluations of data management, signal detection, risk assessment, and regulatory reporting.
  2. Regulatory Compliance
    Assessing alignment with global standards, including USFDA, EMA, and CDSCO.
  3. Detailed Reporting
    Insightful reports identifying gaps, compliance issues, and improvement areas.
  4. CAPA Plans
    Development and implementation of corrective and preventive actions.
  1. Follow-Up Support
    Ensuring effective corrective actions and ongoing compliance.
  2. Risk Management Reviews
    Optimization of risk minimization and safety strategies.
  3. Expert Guidance
    Strategic advice from experienced pharmacovigilance professionals.

QPPV service

At Navatio Pharma Solutions, we offer expert Qualified Person for Pharmacovigilance (QPPV) services to help pharmaceutical companies meet regulatory requirements while ensuring patient safety. As a trusted partner, our team of experienced professionals provides comprehensive support to manage pharmacovigilance obligations in compliance with European Union (EU) regulations and other global frameworks.

Our QPPV Services Include :

    Regulatory Compliance

  • Ensuring compliance with EU pharmacovigilance regulations (as per Good Pharmacovigilance Practice guidelines).
  • Acting as the primary contact point for regulatory authorities and Health Agencies.

    PV System Oversight

  • Establishing, maintaining, and overseeing the Pharmacovigilance System Master File (PSMF).
  • Monitoring the performance of the pharmacovigilance system to ensure robust risk management processes.

    Signal Detection and Risk Management

  • Overseeing signal detection activities to identify and address potential safety risks.
  • Developing and maintaining Risk Management Plans (RMPs) to safeguard patient health.

    Aggregate Reports Management

  • Preparing and submitting regulatory reports, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
  • Ensuring timely submission of all required reports to regulatory agencies.

    ICSR Oversight

  • Monitoring the collection, processing, and submission of Individual Case Safety Reports (ICSRs) in compliance with regulatory timelines.
  • Supporting data integrity and accuracy in safety reporting.

    Audits and Inspections

  • Supporting pharmacovigilance audits and inspections to ensure readiness and regulatory compliance.
  • Implementing corrective and preventive actions (CAPAs) as needed.

    Round-the-Clock Support

  • Providing 24/7 QPPV availability to address critical safety concerns and urgent regulatory requirements.