Canada to potentially join parallel Scientific Advice with EMA and FDA for Complex Generics
Three years ago The FDA and the European Medicines Agency (EMA) have initiated a pilot program aimed at offering parallel scientific...
Phortas is Thrilled to Announce Our Participation at BioSpain 2023!
At Phortas, we are excited to share some remarkable news with you - we will be attending BioSpain 2023, one of Europe's premier...
What to keep in mind as a developer of Drugs for Rare Diseases?
The definition of rare disease varies across countries and jurisdictions, but it usually takes into account disease prevalence, severity...
How to find an excellent Regulatory Affairs Consultancy?
When working on your drug development projects, you will need to perform a thorough analysis of the information and resources needed to...
Do you use Regulatory intelligence in your daily work?
To stay current with the rapidly changing landscape, regulatory professionals must continuously monitor and identify relevant regulatory...
Daily challenges of Regulatory Affairs Experts and how to overcome them
Let’s be honest, the number of tasks a typical Regulatory Affairs manager is asked to perform during a week can be brutal. Meetings,...
How to become a better Regulatory Affairs Strategist?
Have you ever been told that you are a strategic thinker? As a Regulatory Affairs professional, this is one of the qualities that can...
Cheat-sheet for finding excellent Regulatory Affairs Experts
Finding extraordinary Regulatory Affairs experts who are flexible, knowledgeable and experienced is not an easy task. Luckily there are...
How to talk to Regulatory Affairs Authorities?
Having a teleconference or a face-to-face meeting with Regulatory Affairs Authorities is business-as-usual in our Regulatory Affairs...
To Master or not to Master?
From time to time I get questions from my colleagues and aspiring regulatory professionals about the benefits of the regulatory Master’s...