Pharmacovigilance

Screening of worldwide and local Dutch literature

We monitor local and global literature to identify potential safety concerns for medicinal products, aligning with your screening strategy to stay updated with the latest safety information.

Compiling of periodic safety update reports (PSUR)

We prepare PSURs following regulatory guidelines, providing safety information to evaluate the benefit-risk profile of medicinal products.

Signal detection

Our experts use advanced tools to identify patterns or trends in safety data, helping to detect potential safety concerns.

Pharmacovigilance training

We offer training programs on pharmacovigilance regulations, case processing, signal detection, and risk management, tailored to meet your specific needs.

Compilation of the summary of PV Master File (Module 1.8.1)

We compile the summary of the Pharmacovigilance Master File (PV MF) as required by regulations, providing an overview of the pharmacovigilance system.

Compiling of Risk Management Plans (Module 1.8.2)

We help develop and compile Risk Management Plans (RMPs) in compliance with regulatory requirements to identify and manage product risks.

Submission of cases

We ensure timely and accurate submission of individual case safety reports (ICSRs) to relevant regulatory authorities, meeting all regulatory requirements.

Handling of reports

We manage and process safety reports, including adverse drug reactions (ADRs), product quality complaints (PQCs), and medical inquiries, ensuring proper documentation and compliance.

Audits of pharmacovigilance systems

We conduct audits to assess compliance with regulations and best practices, providing recommendations and support for implementing corrective and preventive actions (CAPA).