Medwisdom

Are You Looking For Reliable Pharmacovigilance Services?

Effective pharmacovigilance helps you monitor, detect, and manage adverse events, keeping your products safe and compliant throughout their lifecycle. Partner with us to safeguard your products and patients with expert pharmacovigilance solutions.

    Pharmacovigilance

    At Medwisdom Lifescience, we deliver industry leading pharmacovigilance services, ensuring safety, efficacy, and quality of pharmaceutical, nutraceuticals, medical device, and cosmetic products. Our experts team assist our clients overcome complex regulatory issues while keeping public health as first priority. We pride ourselves on offering end to end pharmacovigilance service and strategic compliance support to meet global safety standards.

    Pharmacovigilance

    Importance of Pharmacovigilance

    The role of pharmacovigilance extends far beyond regulatory requirements, it is the backbone of patient safety. Pharmacovigilance is important for monitoring of adverse drug reaction (ADR), that helps to ensure that the pharmaceutical products are safe and effective throughout market access. Our pharmacovigilance service support, assist pharmaceutical  companies meeting legal  requirements, enhancing confidence of healthcare professionals and patients.

    Our Pharmacovigilance Solution

    Pharmacovigilance Consulting Services

    We offers customized pharmacovigilance consulting services to individual or pharmaceutical company, assisting them build and manage effective safety monitoring system. From initial planning to post marketing surveillance (Pharmacovigilance), we provides support to your pharmacovigilance needs.

    Pharmacovigilance Process Management

    Our team of experts handles every stage of pharmacovigilance process including:

    1. Case Intake & Management
    2. Individual Case Safety Report (ICSR)
    3. Pharmacovigilance Safety Update Report (PSUR)
    4. Adverse Drug Reaction Reporting (ADR)
    5. Public Benefit Risk Management

    Periodic Safety Update Report

    We are specialized in preparing detailed compliant Periodic Safety Update Report (PSUR) to meet requirements of regulatory authorities worldwide. PSUR provides deep insight into product safety and guiding companies to make informed decisions.

    Risk Management Plan

    We develops extensive Risk Management Plan (RMP) that address potential risk associated with your products. Risk Management Plan outline proactive strategies to identify risk hazards and mitigate them, resulting In high quality process and ensuring patient safety and wellbeing.

    Pharmacovigilance Risk Management Service

    Our pharmacovigilance Risk management service focus on: Identifying potential safety concern, developing strategies to minimize risk, and enhancing safety profile of your product and business. By meeting regulatory requirements and compliance with global regulatory authorities, we assist you in staying ahead of your competitor.

    Drug Safety Pharmacovigilance Service

    We offers drug safety pharmacovigilance services from pre clinical trial to post marketing surveillance, safety data collection, and regulatory submissions. We believe in quality ethics, ensuring your product meets highest safety standards globally.

    We Are Leading Pharmacovigilance Service Provider

    Leading pharmacovigilance service provider in India, recognized as one of the most reliable and trustworthy pharmacovigilance company in India. We bring unmatched expertise to every project. Connect with us today to get the benefits such as:

    Support at every small step

    From consultation to reporting and monitoring of side effects, we provide guidance and support at every stage.

    Global Reach

    We understand the specific regulatory requirements of various countries, ensuring safety compliance for regulatory authorities of different regions like USA, EMEA, ASEAN, CIS, LATAM, and other regions.

    Expert Support

    Our team of experts are from industrial background having in depth knowledge of pharmacovigilance, adverse drug reaction, adverse drug event, and safety monitoring of drugs with regulatory compliance.

    What Our Clients Think About Us

    Biobee General Manager

    As a General Manager, I highly recommend MedWisdom LifeScience Regulatory Services. Their expertise in navigating medical device regulations has been invaluable to our operations.

    imperial Lifesciences Head Regulatory Affairs

    Company services are excellent for CTD compliance and medical devices. Their expert team offers tailored solutions and efficient support. Highly recommended!

    Genes2me Director

    MedWisdom LifeScience Regulatory Services is a top choice for medical device companies. Their expert team offers tailored solutions to navigate complex regulations, ensuring compliance and efficient approvals. Professional and reliable, they are an invaluable partner in the regulatory process.

    Frequently Asked Questions

    Various Indian and International companies provides pharmacovigilance services including Medwisdom Lifescience Pvt Ltd.

    Pharmacovigilance outsourcing involves diverse range of activities to help pharmaceutical companies comply with regulatory requirements. Major services are case processing, risk management plan, periodic safety update report (PSUR), training, audit preparation, and adverse effects reporting.

    Main steps involved in conducting post marketing surveillance (PMS) are:

    • Adverse Event Reporting (ADR)
    • Patient Registries
    • Active Surveillance
    • Database Analysis
    • Risk Minimizing Measures
    • Periodic Safety Update Reporting
    • Collaboration With Regulatory Authorities
    Scroll to Top