Development Safety Update Report (DSUR) Services & PSUR (Periodic Safety Update Report) Services
Integrated development safety update report and periodic safety update report services based on validated data, continuous monitoring, and inspection-ready regulatory documentation.
Periodic Safety Evaluation During Clinical Development
Tracks all safety data collected during trials, integrates clinical and pharmacovigilance findings, and documents medical assessments for each reporting period, supporting regulatory compliance and inspection readiness.
PSURs in Ongoing Benefit–Risk Evaluation
Aggregates global safety data, evaluates cumulative adverse events, monitors literature, and assesses benefit–risk balance. Each PSUR ensures traceable decision-making, regulatory alignment, and long-term management of the safety profile.
Development Safety Update Report Services
We Deliver
Our DSUR services guarantee compliance, traceability, and inspection-ready reporting for all ongoing studies by offering structured support throughout clinical development.
End-to-end DSUR authoring (medical writing + PV alignment)
We offer comprehensive development safety update report or DSUR authoring, combining pharmacovigilance alignment, medical writing, and verified safety data to produce reports that are prepared for submission and review.
DSUR review and
remediation
Our team examines current DSURs, finds any gaps, fixes any discrepancies, and guarantees compliance with both company-specific safety standards and international regulatory requirements.
DSUR program support for multiple studies/regions
While overseeing DSUR programs across multiple studies and geographic regions, we standardize reporting practices, coordinate data collection, and maintain consistent regulatory-compliant documentation.
Authority query support
We provide informed responses to regulatory questions by creating accurate, substantiated arguments that back up safety assessments and adhere to inspection specifications.
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Our Periodic Safety Update Report Services
By integrating data analysis, literature monitoring, and structured benefit-risk evaluation for worldwide regulatory compliance, our PSUR services uphold product safety oversight.
End-to-end PSUR authoring
We develop complete periodic safety update reports, 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 periodic safety update report submissions, coordinating filing, formatting, and authority communication to ensure inspection-ready outputs.
DSUR Outputs
You Can Rely On
- Fully authored, inspection-ready Development Safety Update Reports (DSURs)
- Integrated clinical and pharmacovigilance data
- Traceable medical assessment and signal evaluation
- Harmonized reports across studies and regions
- Defensible documentation ready for regulatory submission and audits
PSUR Deliverables Built for Review and Submission
- Complete Periodic Safety Update Reports (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
1
Kick-off: Work with sponsors or CROs to coordinate objectives, timelines, and legal requirements in order to establish reporting scope and deliverables.
2
Data collection and reconciliation: gather safety and safety data, fix discrepancies, and ensure accurate, traceable datasets.
3
Medical writing includes draft DSURs or PSURs with integrated safety analysis, signal evaluation, and regulatory-compliant narratives.
4
Review cycle management: to maintain version control, apply changes, monitor changes, and coordinate sponsor/CRO input.
5
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 Development Safety Update Report
Lab results, literature reviews, pharmacovigilance databases, cumulative safety data, clinical trial case reports, and regulatory correspondence. All inputs are combined, checked, and arranged to allow for accurate DSUR and PSUR preparation.
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
- In order to keep the schedule on track, feedback during review cycles
- Information on regulatory expectations and regional requirements
- Provision of critical applicant information for inspection-ready submissions
Engagement Options We Provide
Full-service DSUR and PSUR authoring, targeted review and remediation, program support across multiple studies or regions, and authority query assistance are examples of flexible engagement models that let customers choose support based on the regulatory requirements and project scope.
Why Choose DrugCard for a Partnership
DrugCard offers assured drug development safety update report services and PSUR services, which are regulatory compliant, inspection ready, and have a smooth review cycle. In this way, customers get traceability, quality, and assured safety data consistency.
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- Anwers your additional questions
- Implenetation DrugCard to your pharmacovigilance system
- Tariff plans, pricing, addional features
