The European Directorate for the Quality of Medicines & HealthCare (EDQM) are currently implementing a “new-look” CEP (Certificate of Suitability). This is following a public consultation with stakeholders which in turn led to the launch of the project CEP 2.0. The aim of the project was to provide greater transparency and reduce the regulatory burden. […]
With our new logo and new website we expect some new visitors, so, I decided to go back to basics for those who may be new to Regulatory Affairs. (If you need help with the jargon visit our A-Z Glossary of Regulatory abbreviations) So, let’s start with the Legal Basis which forms the first step […]
Well, I am fresh back from CPHI 2023, held in Barcelona this year and here are some of the highlights: This year was the busiest CPHI yet and the atmosphere on the show floor was vibrant. Over 52,000 passionate professionals from around the world gathered in the massive conference centre (Fira Gran Via) to connect […]
Welcome to our new Website (we love it !!) As most of you are aware by now, we changed our company name from Ivowen to European Regulatory Affairs Limited in 2020. So much has happened since then (both personally and professionally) and now it is time to take our next steps into this new chapter, […]
We have some exciting news to share – as many of you are aware the company’s name changed to ‘European Regulatory Affairs’ in 2020 and we have continued trading as ‘Ivowen’ to facilitate this transition. After many years as ‘Ivowen’ we are thrilled to announce that we are shedding our old moniker and stepping into […]
Dungarvan Enterprise Centre,
Old Friary Building,
Lower Main Street, Dungarvan,
Co. Waterford, X35 FX45,
Ireland.