Pharmacovigilance
We provide services on pharmacovigilance system set up and monitoring adverse events resulting from the administration of drugs.
JDP provides a comprehensive array of pharmacovigilance and post-marketing surveillance services aimed at guaranteeing the safety and effectiveness of your pharmaceuticals. Our staff of skilled and knowledgeable experts is capable of managing every facet of pharmacovigilance, including risk assessment, signal identification, and case processing and reporting. We gather, manage, and analyze pharmacovigilance data from a variety of sources, including literature, social media, spontaneous reports, clinical trials, and state-of-the-art technologies and systems. Additionally, we abide by the most recent regulations and directives issued by several organizations, including the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO).
Some of the key features of our pharmacovigilance service are:
From pre-approval to post-marketing, we offer complete and specialized solutions for every stage of the product lifecycle. We are able to assist you with a variety of services, including medical information, medical writing, literature surveillance, qualified pharmacovigilance personnel, safety management plans, benefit-risk assessments, clinical trial safety, pharmacovigilance system master files, and more.
We have offices and affiliates in more than 50 countries, demonstrating our global reach and presence. Pharmacovigilance activities can be managed by us in a variety of languages and geographical areas, and we guarantee accurate and timely report submission to the appropriate authorities. Additionally, we have access to regional and global databases and pharmacovigilance information sources.
We conduct our pharmacovigilance operations in accordance with the strictest quality and compliance guidelines. Good Pharmacovigilance Practices (GVP) and other relevant rules and regulations are adhered to by us. In order to guarantee the caliber and integrity of our pharmacovigilance systems and procedures, we also carry out routine audits and inspections.
We improve our pharmacovigilance performance and capabilities by utilizing innovation and technology. Pharmacovigilance tasks including case intake, data entry, medical assessment, and reporting can be automated and optimized with the help of artificial intelligence, machine learning, natural language processing, and big data analytics. To increase the security, scalability, and interoperability of our pharmacovigilance systems and data, we also employ blockchain, cloud computing, and smart contracts.
We believe that our pharmacovigilance service is a key differentiator for our clients, as it helps them to ensure the safety and well-being of their patients and customers, and to achieve their business and regulatory goals. We are proud of our pharmacovigilance service and its capabilities, and we invite you to learn more about how our pharmacovigilance service can benefit you and your products.