Understanding of the risk/benefit ratio associated with pharmaceutical products brings with it the need for more efficient and effective pharmacovigilance solutions. Continuous monitoring of adverse events within the pharmacovigilance system is a regulatory requirement in each country.
2GL Outsourcing provides a comprehensive and flexible solutions for the active management of drug safety, pharmacovigilance and risk management during the complete lifecycle of a medicinal product. We offer you a Qualified Person Responsible for Pharmacovigilance (QPPV) services, which includes having an overview of the safety profiles and any safety concerns in relation to the medicinal products and reporting of adverse reactions related to them, both locally and worldwide. We as well keep up with latest literature information regarding adverse events, writing of Periodic Safety Update Reports (PSURs), communicating with Regulatory Authorities and so on.