Aggregate Report Writing Services

Yashfin specializes in the preparation, review, and submission of high-quality aggregate safety reports in compliance with EU and global pharmacovigilance regulatory standards.
Our experienced pharmacovigilance and medical writing team ensures accuracy, consistency, scientific integrity, and timely delivery across all required aggregate reporting formats.

Aggregate Reports

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PSUR, PBRER & ACO Reports (EU-Compliant)
End-to-end generation, review, and submission of PSUR, PBRER, and ACO reports in line with EU GVP Module VII requirements.

DSUR Preparation Support
Preparation and review of Development Safety Update Reports (DSURs) as required during clinical development phases.

Local Country Chapter Development
Inclusion of country-specific annexes and chapters to meet regional regulatory and local authority requirements.

Generic & Innovator Product Expertises
Proven experience across generic, branded, and innovator products, including diverse therapeutic areas.

SOP-Driven & Quality-Controlled Processes
Reporting activities governed by validated SOPs, ensuring standardized workflows, consistency, and inspection readiness.

A regulator-ready, scientifically robust aggregate reporting framework that supports benefit-risk evaluation, regulatory compliance, and global pharmacovigilance obligations.

Contact Us

B04-332, Business Center 03, RAKEZ Business Zone-FZ,
Ras Al Khaimah, UAE
+971 55 895 5849
info@yashfin.net
info@yashfinpharma.com

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Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.

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Characteristics

Aggregate Report Writing Services