EudraVigilance
EudraVigilance Registration for the electronic exchange of pharmacovigilance information data being a prerequisite for electronic reporting. ·
We help in the registration of MAHs in EudraVigilance as prerequisite for electronic reporting and electronic data interchange of pharmacovigilance information in the EEA. · We help to Obtain MedDRA licence and EUCT (CTIS) number. · We assist pharmaceutical companies holding or applying for a marketing authorization in the
European Economic Area (EEA), clinical trial sponsors and national competent authorities in the EEA that need to register with EudraVigilance for electronic data exchange of pharmacovigilance information. This registration process is a prerequisite for electronic reporting.
Why is it important?
Vigilance is a key responsibility of the MAH and therefore our dedication is addressed to ensure the safety and efficacy of human health products, especially pharmaceuticals, throughout the product life cycle, from development to post-marketing”.Â
The safety problems of pharmaceutical products are the most feared, along with those of manufacturing quality. They can lead to the withdrawal of a drug, the recall of a batch or even the recall of a product.
Why QbD Group?
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
