EU Vigilance Ltd. has been providing pharmacovigilance support, safety surveillance and risk management planning since 2008 within the European Union to SMEs (small and medium sized Enterprises) to ensure their products comply with ever-increasing safety standards.
The requirement for an accurate and comprehensive pharmacovigilance system that will monitor risk/benefit profiles throughout the clinical trial and post-marketing phases is essential for the protection of patients and public health.
In 2012, new EU directives and regulations were implemented to enhance the way in which patient safety monitoring is conducted. Many of these new requirements add significant burden both in terms of resources, expertise and time needed to ensure compliance.
EU Vigilance Ltd can provide the pharmacovigilance and risk management expertise to ensure products comply with these increasingly stringent safety requirements, together with local national representation, particularly in those markets, where this is mandatory. Our solutions are tailored to fit with your strategic aims, funding stage, budget and timelines.
Our experienced team includes an European Qualified Person for Pharmacovigilance, locally acknowledged vigilance officers and safety physicians. EU Vigilance disposes also networks of contacts and cooperation partners in all ICH regions.
EU Vigilance has 3 Local Offices, which are led by the Directors. Moreover EU Vigilance can offer many Local Representations distributed in whole Europe. You can find a map include contact-details in “Contact us”.
Fax : +49.89.922003.90