Overall responsibility
Place your pharmacovigilance affairs in experienced hands. We provide the Qualified Person for Pharmacovigilance (EEA-QPPV) or the graduated plan officer (Stufenplanbeauftragter) in accordance with the German Drug Law. In addition, we take care of all operational activities: from case management to monitoring the risk-benefit profile of your medicinal products.
Closer to the market and the authorities
Our experts (physicians) support you as EEA-QPPVs or graduated plan officers. In this way you avoid nonconformity reports and fulfil your obligation to notify the authorities.
Customised case management
We provide you with holistic case management: recording, medical evaluation, database entry and the reporting of cases of adverse drug reactions. Our team will coordinate the entire case management process or your follow-up activities on your behalf. Our products Vigilit® and Vigicare® are key elements in the management of adverse drug reactions.
Valid statements on your risk-benefit profile
We keep an eye on your PSUR deadlines and prepare your PSURs in accordance with currently valid statutory provisions. Following consultation with you we submit them to the authorities on your behalf.
Safe drugs for patients
In line with your specific requirements we monitor the safety profile of your medicinal products and carry out signal detection.
