PSUR (Periodic Safety Update Report) Services

PSUR (Periodic Safety Update Report) Services*

Integrated periodic safety update report services based on
validated data, continuous monitoring, and inspection-ready
regulatory documentation.

*PSUR in PBRER format

PSURs in Ongoing Benefit–Risk Evaluation

Aggregates global safety data, evaluates cumulative adverse events, monitors literature, and assesses benefit–risk balance. Each PSUR or periodic safety update report ensures traceable decision-making, regulatory alignment, and long-term management of the safety profile.

Our Periodic Safety Update Report Services

Our Periodic Safety Update Report (PSUR) services integrate data analysis, literature
monitoring, and structured benefit-risk evaluation for worldwide regulatory compliance, upholding product safety oversight.

End-to-end PSUR authoring

We develop complete PSURs , consolidating global safety data, performing medical review, and producing reports that reflect comprehensive benefit–risk assessments.

PSUR refresh/update

We make sure that all information is up to date and in line with regulatory requirements by updating existing PSURs with new case data, literature, and signals.

PSUR review and remediation

To ensure complete regulatory compliance and an open safety assessment, our team audits PSURs, finds any gaps or
inconsistencies, and corrects reports.

PSUR submission support

We assist with PSUR submissions, coordinating filing,
formatting, and authority communication to ensure
inspection-ready outputs.

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PSUR Deliverables Built for Review and Submission

Complete PSURs with benefit–risk evaluation
Consolidated global safety data and literature monitoring
Updated case reports and signal analysis
Transparent medical review and regulatory alignment
Audit-ready formatting and submission support
Consistent reporting across the product lifecycle and regions

How we work

Kick-off: Work with MAHs or CROs to coordinate objectives, timelines, and legal requirements in order to establish reporting scope and deliverables.

Data collection and reconciliation: gather safety data, fix discrepancies, and ensure accurate, traceable datasets.

Medical writing: draft PSURs with integrated safety analysis, benefit-risk evaluation, signal detection, and regulatory-compliant narratives.

Review cycle management: to maintain version control, apply changes, monitor changes, and coordinate MAH/CRO input.

Finalization and handover: generate reports that are ready for inspection, provide finished
paperwork, and assist with any additional
questions or clarifications.

Data Inputs We Typically Use for PSUR Preparation

Literature searches, pharmacovigilance systems, safety summaries, case reports from
clinical trials, post-marketing surveillance studies, signal management outputs, and
communication with regulatory authorities. All these inputs are integrated, validated, and organized for effective preparation of PSURs.

Timelines and What We Need From You

Explicit project start dates and due dates for reports
Availability of pharmacovigilance and clinical datasets
Submission frequency of case studies, research updates, and literature reviews
Timely feedback during review cycles to keep the schedule on track
Information on regulatory expectations and regional requirements
Provision of critical applicant information for inspection-ready submissions

Common PSUR Issues We Fix

Many companies struggle with the same recurring challenges in PSUR preparation and submission. Our team identifies and resolves the most frequent issues, including:

Incomplete or inconsistent adverse event data across reporting periods
Gaps in literature monitoring coverage or documentation
Misalignment between safety data and benefit–risk conclusions
Non-compliance with regional regulatory formatting requirements
Delayed submissions due to poor version control or review cycle management
Inadequate signal detection documentation and follow-up

Engagement Options We Provide

Comprehensive PSUR services, targeted review and remediation, program support across multiple products or regions, and authority query assistance — flexible engagement
models that let customers choose support based on regulatory requirements and project scope.

Why Choose DrugCard for a Partnership

DrugCard offers assured PSUR services, which are regulatory compliant, inspection-ready, and supported by a smooth review cycle. Customers benefit from full traceability,
consistent quality, and assured safety data integrity across the entire product lifecycle.