Good Pharmacovigilance Practices (GVP)
Good Pharmacovigilance Practices (GVP)
- PV Process Audits: Our experienced team conducts rigorous audits of the pharmacovigilance processes of sponsor country organizations. These audits assess the effectiveness and compliance of pharmacovigilance activities, helping organizations identify areas for improvement.
- Quality Management System: We assist companies in developing and implementing robust Quality Management Systems (QMS) for pharmacovigilance. Our tailored solutions ensure adherence to regulatory requirements and best practices, enabling effective management of safety data.
- Drug Safety Unit: We provide comprehensive support in managing the entire drug safety lifecycle, from case receipt to submissions, safety surveillance, and aggregate reporting. Our services ensure timely and accurate reporting of adverse events, facilitating compliance with regulatory obligations.