Our QPPV Services Include:
Regulatory Compliance Oversight
Ensuring compliance with European Union (EU) and other international pharmacovigilance regulations, including the maintenance of the Pharmacovigilance System Master File (PSMF).
24/7 Availability
Providing around-the-clock availability to address safety concerns and regulatory inquiries, ensuring continuous compliance and patient safety.
Signal Management
Monitoring safety data, detecting and evaluating signals, and recommending appropriate actions to mitigate risks.
Risk Management Plan (RMP) Oversight
Developing and implementing effective RMPs in alignment with regulatory requirements to proactively manage and mitigate risks associated with your products.
Audit and Inspection Readiness
Preparing for and supporting pharmacovigilance audits and regulatory inspections, ensuring your organization is always ready to demonstrate compliance.
Periodic Safety Reports
Overseeing the preparation and submission of safety reports, including PSURs, PBRERs, and DSURs, to meet global regulatory obligations.
Adverse Event Reporting Compliance
Ensuring the timely and accurate submission of Individual Case Safety Reports (ICSRs) to regulatory authorities in accordance with regional timelines.
Cross-Functional Collaboration
Acting as a key liaison between your organization and regulatory authorities, as well as internal teams, to ensure seamless communication and compliance.
Why Choose Pharmnova for QPPV Services?
Experienced Team
A team of qualified and experienced QPPVs with extensive knowledge of global pharmacovigilance regulations.
Expertise
Proven expertise in managing pharmacovigilance systems for diverse products, including small molecules, biologics, and advanced therapies.
Customized Solution
Commitment to delivering patient-centric and regulatory-compliant solutions tailored to your organization’s needs.
Quality and Compliance
Continuous support to ensure regulatory requirements are met, even in the face of evolving guidelines.
Expert Oversight for Your Pharmacovigilance Compliance!
With Pharmnova’s QPPV services, you can rest assured that your pharmacovigilance system is managed with the highest level of expertise, ensuring compliance and building trust with regulators and stakeholders.
Let Pharmnova’s QPPV team guide you through the complexities of pharmacovigilance with confidence and precision.