Acorn Regulatory’s consultants are experts in the sector. Members of our team have written extensively on this website and in other industry publications about the issues associated with marketing authorisations and much more. Below we have highlighted just four articles that our team members have written on the subject in recent times.
In this blog we look at the initial steps that need to be taken when applying for a marketing authorisation for a pharmaceutical product within the EEA. Read the article here.
Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations and the critical issues that you need to be aware of when completing a variation. Read more here.