Three years ago The FDA and the European Medicines Agency (EMA) have initiated a pilot program aimed at offering parallel scientific...

At Phortas, we are excited to share some remarkable news with you - we will be attending BioSpain 2023, one of Europe's premier...

The definition of rare disease varies across countries and jurisdictions, but it usually takes into account disease prevalence, severity...

What became evident with the introduction of the Paediatric Investigation Plan (PIP) procedure in Europe is that Regulatory Experts need...

When working on your drug development projects, you will need to perform a thorough analysis of the information and resources needed to...

To stay current with the rapidly changing landscape, regulatory professionals must continuously monitor and identify relevant regulatory...

Let’s be honest, the number of tasks a typical Regulatory Affairs manager is asked to perform during a week can be brutal. Meetings,...

Have you ever been told that you are a strategic thinker? As a Regulatory Affairs professional, this is one of the qualities that can...

Finding extraordinary Regulatory Affairs experts who are flexible, knowledgeable and experienced is not an easy task. Luckily there are...

Having a teleconference or a face-to-face meeting with Regulatory Affairs Authorities is business-as-usual in our Regulatory Affairs...