Ensuring Patient Safety Beyond Clinical Trials
At BioVigilant Pharmacovigilance, we understand that drug safety does not end with clinical trials. Our Post-Marketing Safety Surveillance (PMSS) services are meticulously designed to ensure that the safety of your pharmaceutical products is monitored and maintained throughout their lifecycle. From effective management of safety reports to regulatory compliance across diverse markets, we offer comprehensive solutions tailored to meet global standards.
Our Services Include:
ICSR Management and Regulatory Submissions
Effective management of Individual Case Safety Reports (ICSRs) is critical for post-marketing surveillance.
PV System Master File (PSMF/PvMF) Management
A well-maintained Pharmacovigilance System Master File (PSMF) is the cornerstone of regulatory compliance.
Product Label Management
Maintaining accurate and updated product labels is essential for patient safety and regulatory compliance.
QPPV/LRPV Services Across Europe & ROW Markets
Our Qualified Person for Pharmacovigilance (QPPV) and Local Responsible Pharmacovigilance (LRPV) services are designed to meet regional requirements and ensure compliance.
Risk Management Plan (RMP)
An effective Risk Management Plan (RMP) is vital for proactive identification and mitigation of risks.
Additional Risk Minimization Measures (aRMM)
We provide expertise in designing and implementing targeted risk minimization measures.
Global Literature Search and Review
We conduct comprehensive literature searches to identify safety signals and ensure regulatory compliance.
Aggregate Report Writing (PSUR, PADER, PBRER, etc.)
Our team specializes in preparing high-quality aggregate reports to meet regulatory requirements.
Why Choose BioVigilant for
Post-Marketing Safety Surveillance?
At BioVigilant Pharmacovigilance, our focus is to ensure that your products remain safe and effective in the real world. With our expertise, you can confidently navigate the complexities of post-marketing safety while prioritizing patient well-being.
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