Regulatory Services
Pharmacovigilance
We provide Pharmacovigilance and Drug Safety services tailored to our clients’ requirements. Our service is not geographically restricted only to RAW countries. On the contrary, we have been successfully handling clients from all over the world. Pharmacovigilance consulting services offered by us is not limited to consulting services – e.g., benefit-risk analysis, Safety data exchange agreement (SDEA) development, and development of standard operating procedures (SOPs), aggregate report writing (Periodic safety update report/ Periodic benefit risk evaluation report, Development safety update report, Periodic adverse drug experience report), clinical trial and post-marketing case processing, safety database, regulatory reporting, literature search, development of the pharmacovigilance system master file (PSMF), publishing and submission. As a pharmacovigilance service provider, we guarantee to our clients not only effectiveness, but also compliance, conformity, continuity, and reliability. As this is paramount to the successful delivery of any project, we will provide experienced and capable project managers with extensive experience, excellent communication skills and robust management/organizational skills.