Clinical Research Solutions
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
Clinical Research Solutions
The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...
Clinical Research Solutions
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
Regulatory Sciences
Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...
Clinical Research Solutions
Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....
Regulatory Sciences
Do you really know how to accelerate the approval of your innovative product in Europe? The FDA's incentives for promising new medicines are widely known. Accelerated approval, priority review, fast...
Clinical Research Solutions
Are you using Microsoft Excel spreadsheets for GxP activities? Are these Excel sheets used again and again, as a template? Ever thought about validating your spreadsheet templates? Is the person who...