Most Read Pharmaceutical Articles of 2019

Our expert team has written hundreds of well received and widely shared articles in recent years.  This year, they wrote over one hundred expert articles on a wide range of subjects.  below, we have featured some of the most read articles from our CMC and eCTD teams.

What Are The Key Factors To Consider When Planning To In-Licence An eCTD Dossier?

In this article we are taking a look at 4 key factors to consider when planning to in-licence an eCTD dossier.

When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully.  For instance, the eCTD version specific information and tool capability is crucial to import from one system to another.  Try to ensure the version number of the DTD/specification is equal to or lower than the software you will be using in-house or else you may need to upgrade software when it comes time to submissions which may lead to unplanned extra costs.  Read more here.

What You Need To Know About MRP Grouped Variations

Previously, we have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations with clients.  A number of clients have asked us to write about the issue.   Here, we have outlined an overview on the topic. of MRP Grouped Variations.  Read more here.

Can You Use A U.S. Dossier To Apply For A European Marketing Authorisation?

Over the years, we have worked with a significant number of US innovator companies and supported them getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the issues we have encountered in taking a US developed dossier for a new marketing authorisation application in Europe on behalf of a client.  Read more here.

UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?

The original version of this article was our most read article of 2017. Because regulatory professionals need access to the most up to date and relevant information, we have updated the article and extended it to take into consideration a number of developments.   Read more here.

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