vigilance & quality services

Our interdisciplinary team supports you in the following topics with high professional competence and long-standing experience and is flexible in cushioning your capacity constraints:

Services offered include the taking over of operational activities, establishment of new systems and optimisation of existing systems and processes as well as consulting. We reduce your workload and enable you to concentrate more closely on your core processes and core competences.

Up-to-date: Brexit will Turn U.K. into a “Third Country“ from 30th March 2019

Following the Brexit, the United Kingdom (U.K.) will become a “third country”. From 30th March 2019 marketing authorisation holders of medicinal products based in the U.K. will need to have a registered office and/or a manufacturing site with a corresponding manufacturing authorisation in the EU and/or the EEA. For batch-release and pharmacovigilance activities in the EU/EEA the QP and QPPV will also have to be resident there. This is clarified by the European Commission and EMA in their Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use", published in May.

HWI Campus supports companies with their entry into the EU and offers attractive and efficient solutions concerning registered office, QM, EU batch release, pharmacovigilance, life-cycle management and much more. Further information about HWI Campus.

Contact: Dr. Yvonne Haagen, Head of Vigilance & Quality Services
Email: y.haagen(at)hwi-group.de
Phone: +49 7272 7767-2532

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