At feyti, we provide high-quality and cost-effective pharmacovigilance solutions to pharmaceutical and biopharmaceutical companies. Pharmacovigilance, also known as drug safety, plays a critical role in ensuring the safety of marketed medications by monitoring and evaluating adverse drug reactions (ADRs). We have a team of experienced and qualified professionals who handle all aspects of pharmacovigilance, from clinical trials to post-marketing surveillance. We use state-of-the-art technology and systems to collect, manage, and analyse safety data and generate insights that can improve patient outcomes.
Our pharmacovigilance services include:
Case Processing: We collect, enter, assess, and report individual case safety reports (ICSRs) from various sources, such as spontaneous reports, clinical trials, literature reviews, social media, etc. We ensure compliance with global and local regulatory requirements and guidelines.
Safety systems and reporting: We use advanced safety databases and tools to store, retrieve, and submit safety data to regulatory authorities and clients. We also prepare and review periodic safety update reports (PSURs), Label review, development safety update reports (DSURs), risk management plans (RMPs), and other aggregate reports.
Qualified Person for Pharmacovigilance (QPPV) Services: We offer Qualified Person for Pharmacovigilance (QPPV)services to ensure that our clients have a fully compliant pharmacovigilance system in place.
Audits and inspections: We conduct internal and external audits and inspections to evaluate the quality and performance of our client's pharmacovigilance system and processes. We also assist them in preparing for and responding to Regulatory and Quality audits and inspections.
Literature Surveillance: We continuously monitor the scientific and medical literature to identify new ADRs or safety concerns related to marketed medications.
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Pharmacovigilance Services
