Drug safety / Pharmacovigilance

At RAY CRO, our commitment to patient safety is paramount. We have been at the forefront of providing comprehensive pharmacovigilance services that ensure the highest standards of drug safety across all stages of the product lifecycle.

Our dedicated Pharmacovigilance team offers a full suite of services tailored to meet the regulatory requirements and specific needs of our clients. These include:

Adverse Event Reporting and Management

We handle the collection, processing, and submission of adverse event reports, ensuring compliance with local and international regulations.

Signal Detection and Risk Management

Our experts utilize advanced methodologies for signal detection and risk evaluation, allowing for proactive management of potential safety issues.

Global and Local Literature Screening

ontinuous monitoring of scientific literature to identify new safety signals and emerging risks related to medicinal products. We are using our Validated Literature Review Software INFODEX.

Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)

Comprehensive preparation and submission of these critical regulatory documents, providing an ongoing assessment of product safety.

Case Processing

Efficient and accurate management of individual case safety reports (ICSRs) to ensure timely submissions to regulatory authorities.

Pharmacovigilance System Master File (PSMF) and subsystem master file (PSSF) Maintenance

Development, maintenance, and auditing of PSMFs and PSSF to ensure compliance with global regulatory standards.

Local and Global Pharmacovigilance Support

With our strategic presence in the MENA region and a global network, we offer localized support while maintaining global oversight and coordination.

QPPV /LSR Full Services

Outsourcing the QPPV/LSR function can provide a cost-effective solution to gaining access to the required expertise of a QPPV/LSR

PV Audits

We offer a complete range of PV audits including MAHs, Local affiliates, Vendor and Co Marketing Partner Audit, with recommended CAPAs & Audit Certificate. We are covering Middle East, Africa, Europe and Asia.

PV SOP Writing

RAY CRO offers expert SOP writing services to ensure your pharmacovigilance processes are compliant, streamlined, and aligned with regulatory requirements.

PV Training

At RAY CRO, we offer comprehensive Pharmacovigilance training programs designed to equip trainees with the knowledge and skills needed to manage drug safety effectively.