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Post authorisation safety studies (PASS) are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine […]
The TOPRA Symposium 2019 will bring over 700 regulatory professionals to Dublin, Ireland to hear from a wide range of […]
DEKRA, the German based company, has been chosen by The European Commission as the third notified body to be accredited […]
In this article we are taking a look at 4 key factors to consider when planning to in-licence an eCTD […]
Acorn Regulatory has been shortlisted at the 2019 Pharma Awards in the Pharma Contract Services Company of the Year category. Founded […]
Type I Variations to a Marketing Authorisation are surprisingly difficult. The procedure that many people perceive to be a simple […]