Pharmacovigilance Services: Your Partner for Patient Safety

Case management is essential for identifying and evaluating adverse events, facilitating effective adverse event reporting, and ensuring compliance with regulatory authorities. This process is integral to clinical site management, as it ties into quality management services and medical writing, ultimately contributing to efficient signal management.

Global and local literature monitoring are essential sources for adverse event reporting, helping to identify safety information crucial for clinical site management. These processes are integral to effective medical writing and quality management services, as well as signal management in the healthcare industry.

We provide a scientific compilation of medical writing reports, including RMP, PSUR/PBRER, PADER, DSUR, and Addendum to clinical overview, to ensure global compliance and an optimal risk-benefit profile of medicinal products. Our quality management services also encompass adverse event reporting and effective signal management, enhancing clinical site management throughout the process.

We have a team of experienced QPPVs located in the EU & UK, who are well-versed in adverse event reporting and clinical site management. Additionally, we have qualified vendors for local QPPVs covering the EU & RoW, ensuring comprehensive quality management services and effective signal management.

Our robust signal management process is designed to meet both global and local regulatory requirements, ensuring effective adverse event reporting and clinical site management. Additionally, our quality management services encompass medical writing to support all aspects of the signal management lifecycle.

We have a dedicated team of experts managing our client's needs for global and local PSMF, including adverse event reporting, clinical site management, medical writing, quality management services, and signal management.

 Eliminate EU market risk with guaranteed accuracy and timely submission of all Article 57 data requirements. Our certified experts manage continuous product dictionary updates.

 We provide real-time updates on evolving PV legislation across 150+ countries. We turn complex regulatory changes into proactive compliance strategies, safeguarding your patient safety commitments and license standing.