Regulatory Affairs and Pharmacovigilance – zelhealth allows you to effectively outsource regulatory processes – completely or in parts – during the course of the drug registration. These services include preparing the optimum regulatory strategy and creating the regulatory dossier as well as supervision of the official application for approval until registration is granted. Regulatory maintenance is provided as well. Communication with authorities will be provided in the respective national language.
zelhealth is your partner for establishing quality management systems and provide advice on quality assurance systems. We develop risk management plans to provide you with support in complying with guidelines and legal obligations in the area of pharmacovigilance. If required, we provide you with one of our QPs, QPPVs or offer to outsource your drug safety completely.
We also provide similar services in the area of medical devices. zelhealth offers comprehensive guidance during the entire conformity evaluation procedure for CE certification with notified bodies and the registration of your products worldwide.
Because requirements are constantly increasing with regard to market surveillance of medical devices, we offer a wide variety of services for ensuring vigilance compliance. These services include support for risk management during all product lifecycles of your medical devices according to ISO 14971 as well acting as Responsible Person for Medical Device Safety (Sicherheitsbeauftragter according to the German MPG).
