Aggregate Safety Reports Services
DDReg offers comprehensive aggregate safety reporting services that enable pharmaceutical companies to maintain a clear and compliant benefit-risk profile of their products throughout the lifecycle. Our expert team specializes in the preparation and submission of PSURs, DSURs, and other safety documents in accordance with global standards set by ICH, EMA, and the U.S. FDA. With robust data analysis and regulatory insight, we help streamline compliance, reduce risk, and ensure timely global submissions.
DISCOVER MOREOur Approach to Aggregate Reporting Services
In today’s dynamic regulatory landscape, a detailed analysis of a product’s benefit-risk profile requires more than just individual case study reports. We specialize in periodic safety reviews that compile essential data accumulated by Marketing Authorization Holders (MAH). Our process is designed to address regional differences in report submission frequency, ensuring consistency and avoiding duplication of effort while adhering to evolving safety regulations from agencies like the U.S. FDA and EMA.
Our team conducts meticulous evaluations of adverse drug reactions (ADRs) and serious adverse events (SAEs) to create a holistic view of a product’s safety. By leveraging our proven methodology, we offer high-quality aggregate reporting services that not only meet regulatory standards but also support proactive risk management and data-driven decision-making in pharmacovigilance.
Comprehensive Pharmacovigilance Aggregate Reporting
DDReg provides end-to-end solutions for pharmacovigilance aggregate reporting—from pre-submission analysis to post-marketing evaluations. Our services include the preparation of detailed periodic safety update reports and other critical documents required by global regulatory authorities. We ensure that every report, whether it is a pre-approval aggregate report or a routine periodic submission, is compiled with precision and in accordance with ICH, EMA, and U.S. FDA templates.
Utilizing advanced in-house tools and robust databases, our dedicated team of life science experts manages the entire process of research, data collation, authoring, and quality review. This systematic approach minimizes errors and streamlines the submission process, making us a trusted partner for organizations facing the complex challenges of aggregate reporting in pharmacovigilance.
Our Aggregate Reporting Expertise
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
Are you ready to optimize your pharmacovigilance reporting and ensure robust drug safety?