Think about the last time you took medication—whether it was for headache, cold, or chronic condition. Did you ever stop to wonder, “How do I know this drug is safe…

We often focus on clinical trials when thinking about the safety and effectiveness of medicines and devices. But what happens after a product is approved and widely used? That’s where…

A Qualified Person for Pharmacovigilance (QPPV) plays a crucial role in ensuring patient safety and regulatory compliance in the pharmaceutical industry. As more countries enhance their pharmacovigilance (PV) systems, the…

In the ever-evolving field of pharmacovigilance, the ability to detect and manage signals effectively plays a pivotal role in safeguarding public health. Signal detection and management in pharmacovigilance involves identifying…

In the dynamic and highly regulated pharmaceutical industry, Local Technical Representatives (LTRs) play a pivotal role in simplifying market entry in Africa. They bridge the gap between regulatory authorities and…

Patient safety drives the pharmaceutical industry, and the Qualified Person for Pharmacovigilance (QPPV) plays a central role in ensuring it remains a top concern by overseeing pharmacovigilance systems, monitoring product…

At Jeyflex Consultants, we pride ourselves in providing world-class compliance design services to pharmaceutical companies. That’s why we were determined to achieve ISO 9001:2015  certification; the globally recognized standard for…

Introduction The advent of the digital revolution has changed many sectors, and regulatory affairs is no different. As technology evolves, so must the frameworks and approaches that regulate it. In…

Introduction Pharmacovigilance services in Kenya play a key role in addressing drug safety. The Pharmacy and Poisons through the Pharmacovigilance Centre, manages these activities in collaboration with healthcare experts, the public and other stakeholders, to promote the effectiveness of pharmacovigilance. Continued efforts are needed to address critical issues such as underreporting and resource limitations. Accountability through the appointment of a qualified Person for Pharmacovigilance  Outsourcing Pharmacovigilance services is an important business model. It can increase efficiency by more than 50 % and save at…