Masuu Global provides end-to-end support in Pharmacovigilance audit and system setup operations, ensuring regulatory compliance, efficiency, and safety in drug monitoring and reporting processes.

Development of SOPs (Standard Operating Procedures):
  • Regulatory Compliance:
    Masuu Global develops SOPs tailored to meet regulatory guidelines, ensuring adherence to GCP (Good Clinical Practice) and GVP (Good Pharmacovigilance Practice) standards.
  • Customization:
    SOPs are customized to fit the specific needs and processes of each client, optimizing PV operations.
Process Training on SOPs:
  • Comprehensive Training Programs:
    Masuu Global conducts process training on developed SOPs, ensuring PV staff are proficient in executing procedures correctly and efficiently.
  • Enhanced Compliance:
    Training programs enhance staff competency and ensure compliance with regulatory requirements.
Work Instructions & Templates Development:
  • Customized Solutions:
    Masuu Global develops work instructions and templates aligned with SOPs, facilitating consistent and standardized PV processes.
  • Efficiency and Accuracy:
    Templates streamline data collection and reporting, improving efficiency and accuracy in PV operations.
Inspection and Audit Support:
  • Mock Audits:
    Masuu Global conducts mock audits to prepare clients for regulatory inspections, identifying areas for improvement and ensuring readiness.
  • CAPA Plans:
    We assist in developing CAPA (Corrective and Preventive Action) plans to address audit findings and maintain compliance.
Medical Information Contact Center (MICC) Setup:
  • Establishment of MICC:
    We set up a Medical Information Contact Center (MICC) to handle inquiries related to drug safety and pharmacovigilance.
  • Toll-Free Number:
    We setup a toll-free number to facilitate easy access for healthcare professionals, patients, and consumers to report adverse events and obtain drug information.
  • Trained Personnel:
    We deploy the trained and experienced personnel to manage the MICC, ensuring accurate and efficient handling of inquiries.
  • 24/7 Availability:
    Our trained and experienced personnel will ensure round-the-clock availability to handle urgent inquiries and adverse event reporting.
  • Multilingual Support:
    We Offer multilingual support to cater to a diverse client base, ensuring effective communication across different regions.
  • Dedicated Lines:
    We set up dedicated lines for adverse event reporting, medical inquiries, and product complaints.
PV System Setup and Optimization
  • Robust PV Systems:
    Masuu Global establishes robust Pharmacovigilance systems, including database validation and development of SOPs tailored to meet global regulatory standards.
  • Database Validation:
    We validate Pharmacovigilance databases to ensure accuracy, reliability, and compliance with regulatory requirements worldwide.
Audit and Compliance Support
  • Pharmacovigilance (PV) Audit Services:
    Masuu Global offers comprehensive Pharmacovigilance (PV) audit services aligned with GCP and GVP guidelines, ensuring adherence to regulatory standards.
  • Training Programs:
    Tailored training programs are provided to enhance PV staff competency and readiness for audits and inspections.
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