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September 9, 2020

EU Paediatric regulation - (EC) No 1901/2006 entered into force on 26 Jan 2007. Its purpose was to improve the health of children in the EU by facilitating the development of safe and effective medicines making sure they are ethically researched, authorised appropriately and by improving the availability of informatio...

July 14, 2020

When working on your drug development projects, you will need to perform a thorough analysis of the information and resources needed to complete all required tasks. It is highly unlikely that all required regulatory and general drug development knowledge, information and skills can be found in-house and therefore you...

March 10, 2020

To stay current with the rapidly changing landscape,  regulatory professionals must continuously monitor and identify relevant regulatory information, and that is not an easy task. Constant change, new technologies and products, regional differences, expansion and harmonization, increased requests for transparency by...

July 8, 2019

Let’s be honest, the number of tasks a typical Regulatory Affairs manager is asked to perform during a week can be brutal. Meetings, calls, coaching, submissions, preparation of responses, team management and hundreds of emails all contribute to the feeling of never-ending daily grind.

Without effective ways to manage...

May 6, 2019

Have you ever been told that you are a strategic thinker? As a Regulatory Affairs professional, this is one of the qualities that can tremendously improve your career, lead to promotions and new business opportunities. Some people are however struggling with strategic thinking and maybe you even got the feedback that...

April 16, 2019

As part of any product development it is of paramount importance to build constructive relationships with Regulatory Agencies. If you intend to bring your product to the USA market you should involve the Food and Drug Administration (FDA) as soon as possible into your product development. This is especially important...

March 30, 2019

Finding extraordinary Regulatory Affairs experts who are flexible, knowledgeable and experienced is not an easy task. Luckily there are some proven methods and “cheats” that can help you find your Regulatory expert without a headache.

  1. Be specific

You really want to look for a company that has a vast experience in...

January 16, 2019

Having a teleconference or a face-to-face meeting with Regulatory Affairs Authorities is business-as-usual in our Regulatory Affairs world. Still, I often get surprised how many people underestimate an overall process of preparation, conduct and closing of interactions with Regulatory Affairs Authorities.

There are som...

August 22, 2018

From time to time I get questions from my colleagues and aspiring regulatory professionals about the benefits of the regulatory Master’s degree and Regulatory Affairs Certification (RAC), since I did them both. So, I decided to shortly address both of them hoping that you will find my observations helpful.

Regulatory A...

July 24, 2018

Contains sarcasm!

OK, so it’s a beautiful day, you came early to the office and you are so ready to spread that Regulatory Affairs love. There are a couple of proven ways to show your expertise, helpfulness and appreciation to your colleagues that will turn you into their favourite colleague in no time:

1. Your colleagu...

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