Postmarketing Auditing
Our auditors and their feedback are highly valuable to your quality management system and help you identify gaps and mitigate them to fulfill the requirements of applicable regulations, guidelines, and standards, and ensure you are always ready for an inspection. We conduct both remote and on-site audits across all aspects of your PV system. In line with GVP Module IV, Mivigilance Group can help implement a risk-based approach to PV audits and create an appropriate audit strategy, effective audit program, and robust CAPA management system.
Postmarketing Safety Reporting
Postmarketing safety reporting is a key step in ensuring patient safety. All the pharmaceutical and biotech companies are required to identify, collect, and process Individual Case Safety Reports (ICSRs) in a systematic manner, and report to regulatory authorities in the required timelines. We enable hassle free case processing, compliant and in accordance to the regulatory requirements.
Global and Local Literature Screening
Literature screening is paramount to identify new signals for emerging safety issues. MIVIGILANCE experts help you screen local and global literature to identify reportable Individual Case Safety Reports (ICSRs) and detect safety signals to ensure your pharmacovigilance (PV) program adheres to the global regulatory requirements.