Pharmacovigilance Expertise
Our team of pharmacovigilance experts offers end-to-end support throughout the entire drug safety lifecycle, ensuring compliance with global regulatory requirements and industry best practices. We help organizations effectively manage drug safety operations by providing tailored solutions that enhance efficiency and regulatory adherence.
Our services include:
- Safety Database Configuration & Setup – We assist in the implementation and optimization of safety databases, ensuring they are configured to meet regulatory standards and operational needs.
- ICSR Triage & Processing – Our experts handle the intake, assessment, and processing of Individual Case Safety Reports (ICSRs) for timely and accurate regulatory submissions.
- Periodic Report Creation & Submission – We manage the preparation and submission of essential regulatory safety reports, including Periodic Safety Update Reports (PSURs/DSURs) and Product Lifetime Listings (PLLs).
- Regulatory Intelligence Monitoring & Maintenance – We continuously track and update global regulatory intelligence databases, ensuring compliance with evolving drug safety regulations and requirements.