Tailor-made solutions for Pharmacovigilance – Ensuring the safety of your medicinal products and Medical Devices
Monitoring the safety of Medicinal Products and Medical Devices – especially with regard to adverse effects – plays an important role in ensuring the safety of products in both the EU and worldwide. A functioning risk management strategy and close cooperation with the competent national and international regulatory authorities (such as EMA and FDA) in the field of the use of Medicinal Products is indispensable. One of our core competences is Pharmacovigilance – i.e. developing and carrying out measures for the continuous and systematic monitoring of medicinal products.
We are also active in the development of Medical Devices and can support you as a service provider in adapting to the new requirements of the Medical Device Regulation (MDR).
Our experts comprehensively research, record and evaluate side effects and other problems associated associated with a medicinal product. This includes impurities and defects in both the product and packaging, errors in the manufacturing process and inaccuracies in the communication of information associated with the medicinal product. We can offer support in ensuring the safety of your Medicinal Product, in analysing side effects and in preventing errors in the application or therapy.