Pharmacovigilance plays a fundamental role in patient care worldwide, as it facilitates the monitoring of drug safety, from the initial evaluations to the mass consumption stage. RAAJ GPRAC offers a 360-degree PV intelligence that can help every Life Sciences organization to create internal Regulatory and PV processes, thereby complying with the HA policies and laws.

We provide Pharmacovigilance and Drug Safety services tailored to our clients’ needs and requirements. Our services are framed within the most updated and best pharmacovigilance practice.

• Audit PV System and support for set up of Quality System
• EU-QPPV and local contact services
• Preparation of PSMF, RMP, PSURs, and handling of Case Management
• Implementation of Adverse Event reporting tool
• Pharmacovigilance Intelligence on Regulations for Individual Countries
• Region-wise Product-specific (Drugs, Device, biologics) Guidance
• Country-specific Regional ICSR and Aggregate Reporting Timelines and Requirements
• Signal management activities, including detection, validation, prioritization, and assessment.