Updating quality documentation

Pharmaceutical quality – for a (medicinal product's) lifetime

You are preparing national variation or renewal applications; EU variations or renewals are pending; or you require expertise on special issues – whatever the case, we provide you with comprehensive support when it comes to marketing authorisation maintenance.

Your documentation benefits from our know-how

Take advantage of our experience and safeguard the quality of your medicinal products after marketing authorisation has been granted. We prepare and update quality documentation, quality overall summaries (human), expert reports (veterinary), quality overviews, expert statements and synoptic comparisons for you.

As part of your marketing authorisation maintenance – or independently thereof – we consolidate dossiers and convert older documents (for human medicinal products) into CTD format. On request, we will also conduct weak-point analyses in the process.

On your behalf we prepare expert opinions and statements on all questions relating to pharmaceutical quality for submission to authorities.