Comprehensive pharmacovigilance services for drug safety and regulatory compliance

At Billev Pharma East, we specialize in providing comprehensive pharmacovigilance solutions to ensure drug safety and compliance with EU and international regulations. Our pharmacovigilance system is designed to support Marketing Authorization Holders (MAHs) throughout the product lifecycle, from development to post-marketing surveillance.

Our services include the implementation and maintenance of a robust pharmacovigilance system master file (PSMF), appointment and support of a Qualified Person for Pharmacovigilance (QPPV), preparation of Periodic Safety Update Reports (PSURs), and development of a tailored pharmacovigilance Risk Management Plan (RMP) in pharmacovigilance.

We follow the latest Good Pharmacovigilance Practice (GVP) guidelines and ensure that all activities are compliant with good pharmacovigilance practices as required by EMA and local authorities. Whether you need full outsourcing or support with specific PV activities, our experienced team is ready to deliver reliable, efficient, and regulatory-compliant solutions.

In addition to core pharmacovigilance services, we offer strategic guidance in the setup and optimization of your internal pharmacovigilance system, including training, SOP development, and quality assurance aligned with good pharmacovigilance practice (GVP). Our proactive approach ensures early detection of safety signals and efficient handling of benefit-risk evaluations. Whether you’re preparing for market launch or scaling your operations, we provide end-to-end support tailored to your product-specific safety profile. Our extensive experience in working with diverse therapeutic areas allows us to adapt your risk management plan in pharmacovigilance to the unique characteristics of each medicinal product.

All our pharmacovigilance activities are handled by qualified professionals with extensive regulatory knowledge and hands-on experience. As your trusted partner, we take responsibility for the entire safety function, from signal detection and case processing to the preparation of high-quality Periodic Safety Update Reports (PSURs) and maintenance of your Pharmacovigilance System Master File (PSMF). With a dedicated Qualified Person for Pharmacovigilance (QPPV) at your disposal, you can be confident in your ongoing compliance with both local and EU pharmacovigilance requirements.