Specialized Aggregate Reporting Services with a Focus on Patient Safety & Product Quality
Pharmaceutical sponors, medical device manufacturers and Market Authorization Holders (MAHs) have the mandatory legal obligation to prepare and submit Aggregate Safety Reports to regulatory bodies as per the requirements described in the ICH Guidelines.
Aggregate Reporting is as an assurance that companies are continously monitoring patient safety and communicating risks to healthcare providers and patients from time to time. These safety reports are typically submitted to regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and are used to inform safety-related decisions, including product labeling, risk management plans, and regulatory action.
Our expert PV Team specializes in working with Sponsors and Marketing Authorization Holders (MAHs) to timely complete safety report authoring, medical review and submission of finalized reports to regulatory agencies with the following capabilities:
- Providing expertise in pharmacovigilance regulations to meet safety compliance
- Preparing accurate safety data tabulations, calculations and line listings
- Drafting safety reports as per the format prescribed by the ICH guidelines
- Completing medical review and timely submission of Safety Reports to Agencies
- Using modern technology to manage the entire Aggregate Reporting lifecycle
- Always meeting timelines and avoiding delays to assure regulatory compliance
Services We Offer
To meet regulatory requirements for aggregate reporting, our closely aligned scientific writing and pharmacovigilance teams, can provide end-to-end support for aggregate reporting and safety writing for all stages of the product life cycle. With our expertise, we support our clients’ PV teams to prepare and maintain the global safety reporting calendar across products.
Additionally, we offer clients our Compier Aggregate Reports module that automates the complete regulatory reporting lifecycle management from pre-approval to post-approval of medicinal products with features like Digital Authoring, Collaborative Review and Insights & Analytics.
Pre-Approval Aggregate Safety Reporting
We support sponsors in preparing summaries about the cumulative safety information in IND / NDA Annual reports to describe potential safety issues and ensure that the benefits of the drug outweigh its risks. The information gathered during pre-market aggregate reporting is used by regulatory agencies, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to make decisions about the approval and labeling of the drug.
Post-market Aggregate Reporting
We work with our client safety team to prepare the following types of Safety Aggregate Reports:
> Periodic Safety Update Reports (PSURs)
> Periodic Benefit-Risk Evaluation Reports (PBRERs)
> Development Safety Update Reports (DSURs)
> Post-Market Surveillance Reports
> Device Malfunction Reports
> Device User Facility Reports (DUFRs)
> Risk Management Plans for new license application and renewal purposes
