Gemma Robinson

Brexit Information for Life Science Companies – June 2018 Edition

The Brexit project is  ever changing and keeping up to date with how it impacts on the life sciences sector… Read more

The Worksharing Procedure for Variations for National Marketing Authorisations in the EU

Did you know that Article 20 of Commission Regulation, known as the ‘Variations Regulation, allows for a Marketing Authorisation Holder… Read more

Our WDA E-Book Is Available To Download Now

The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. … Read more

Is Well Established Use Going Out of Fashion?

The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make.  One… Read more

Four New Countries Join The EU – US Mutual Recognition Agreement for Manufacturing Sites

Four new entrants joined the EU-US Mutual Recognition Agreement for manufacturing sites for human medicines on March 1st.  The four… Read more

Preparing the Reference Safety Information for a Clinical Trial

What are the steps that companies need to take when preparing the reference safety information for a clinical trial?  This… Read more

Brexit Information for the Pharmaceutical Sector

In this blog we look at a number of Brexit information resources for the pharmaceutical sector. 

How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies 

Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices.  The consistent pace… Read more

Blog: The 30% Club Report & Women in Life Sciences

In this blog, Dr. Gemma Robinson looks at the recent 30% Club report and the similarities that can be drawn… Read more