In Regulatory compliance in pharmacovigilance demands meticulous aggregate reporting to ensure the ongoing safety of medicinal products. Our Pharmacovigilance Aggregate Reporting Services empower pharmaceutical companies with precise, timely, and regulatory-compliant safety documentation.
Periodic Safety Update Reports (PSURs/PBRERs): Comprehensive evaluation of product benefit-risk profiles.
Development Safety Update Reports (DSURs): Ensuring regulatory compliance during clinical trials.
Addendum to Clinical Overview (ACO): Expert analyses to complement regulatory submissions.
Risk Management Plan (RMP): Tailored strategies to mitigate risks associated with medicinal products.
Ad-Hoc Aggregate Reports: Custom reports to address urgent regulatory or safety needs.
Regulatory Expertise: Stay aligned with global standards, including EMA, FDA, and ICH E2C(R2).
In-Depth Analysis: Gain insights from real-world data, literature, and spontaneous adverse event reports.
Quality Assurance: Every report undergoes rigorous quality checks to meet audit requirements.
Customised Solutions: Tailored to your product portfolio, therapeutic area, and geographic markets.
Cost & Time Efficiency: Focus on your core operations while we manage complex reporting processes.
With a proven track record of delivering high-quality pharmacovigilance aggregate reports, we ensure compliance, mitigate risks, and enhance patient safety.
Get in touch today to learn how we can simplify your aggregate reporting needs and strengthen your pharmacovigilance system.
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