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ICSR Processing You Can Rely On, and the Person Behind It

Paulina Valuskova, Ph.D. leads our ICSR processing practice. A pharmacist and researcher by training, with experience spanning hands-on case processing, Individual Case Safety Report (ICSR) management, aggregate reporting, and Deputy EU QPPV responsibilities, she brings the scientific rigor and operational depth that safety data demands at every stage.

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Quality systems built to satisfy the world's most demanding regulators.

ICSR PROCESSING

Your safety data, structured
and inspection-ready

Paulina and her team provide end-to-end support across the entire safety data lifecycle, from intake through submission and oversight, so your data is clean, consistent, and ready when it matters most.

Intake Solutions

We help you set up structured, reliable intake flows so information from patients, Healthcare Professionals, partners, affiliates, and literature arrives clean and complete, giving every downstream process a stronger foundation.

Case Processing

We manage end-to-end case processing built on validated intake and medical review, covering data entry, coding, quality checks, and case finalization so each case is complete, consistent, and ready for submission.

Aggregate Reports

Because your inputs are structured and medically validated, we prepare Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Periodic Adverse Drug Experience Reports (PADERs) with clarity and consistency, so reporting is something you can approach with confidence.

Safety Oversight Activities

We provide ongoing safety oversight activities that support compliance and signal awareness, monitoring trends, supporting governance forums, documenting decisions, and ensuring appropriate escalation so safety risks are identified and managed proactively.

Medical Review

Our experts provide clear, consistent assessments of seriousness, causality, and medical relevance so you always know where you stand. With expert oversight built in, your data becomes more reliable and inspection-ready.

Case Submission

We manage deadline-driven case submission aligned with global and local reporting requirements, handling timelines, documentation, and confirmations so cases are submitted accurately, on time, and without last-minute pressure.

Writing and Submitting of Aggregate Reports

We provide expert writing and submission of aggregate safety reports, supported by structured data and medical review. We deliver DSURs, PSURs, PBRERs, and PADERs that are clear, consistent, and inspection-ready.

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