Is Brexit putting your clinical trial at risk?

FAO: ALL UK-BASED SPONSORS OF EU CLINICAL TRIALS If you are a UK-based sponsor with a clinical trial in the rest of the EU, Brexit could have a profound impact on the legal status of your study. Clinical trials in the EU are governed by the Clinical Trials Directive 2001/20/EC. According to Article 19 of […]

Medical Device Regulation: Leveraging expertise from Pharma

When the Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) transition was launched earlier this year, medical device manufacturers were faced with a steep mountain of regulatory, legal, process and resource challenges that would need to be climbed in order to introduce new and continue supplying existing devices for use in healthcare. In […]

Applying for Orphan Drug Designation: Should the USA always be your first regulatory target?

In this article we examine 5 common myths surrounding FDA vs. EMA applications for Orphan Drug Designation applications. Download PDF: Microsoft Word – ODD – Should the USA always be first regulatory target