PrimeVigilance

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PrimeVigilance is the pharmacovigilance and drug safety services business of the Ergomed Group, providing end-to-end safety support across clinical research, regulatory review and registration, and post-marketing phases. Its services cover benefit-risk management, case processing from collection and data entry through medical assessment and expedited reporting, global individual case safety report and aggregate report submission, GVP audits and inspection readiness, and provision of a Qualified Person for Pharmacovigilance and Pharmacovigilance System Master File. Buyers are pharmaceutical and biotechnology companies that must meet regulatory safety obligations for investigational and marketed products without building an in-house safety function. Suggested category: Other Healthcare Services.