Practical activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related issues.
Every company cares about its reputation and, in accordance with international standards, must implement measures to collect, analyze, process, and disseminate information about the occurrence of adverse reactions associated with the use of its products across all territories.
We guarantee strict confidentiality when handling information and respect for intellectual property rights
You don’t have the time or resources — we can help by providing the following services:
- Organization and operation of a local safety monitoring system with the role of a safety-authorized organization, in accordance with your company’s standards and local legal requirements
- Development of documentation for the local safety monitoring system
- Collection and processing of spontaneous reports
- Database maintenance and reconciliation of received and processed data
- Submission support and communication with authorized bodies
- Periodic safety reporting
- Literature screening
- Support during inspections by local authorities and internal audits
- Personnel training
