Welcome Dilyana

We are delighted to welcome Dilyana to the Fusion Pharma team as our newest Regulatory Affairs Consultant. Dilyana joins us with extensive experience gained across both the MHRA and the pharmaceutical industry, bringing valuable insight into the regulatory challenges involved in developing and licensing medicines. Her expertise and collaborative approach make her a fantastic addition […]

National vs IRP – what are the pros & cons

Part of a successful regulatory strategy is to assess all available routes to licensing medicines and select the most appropriate option by carefully weighing the pros and cons of each.   Since Brexit, the regulatory landscape continues to evolve and one of the most popular post-Brexit routes is still the International Recognition Procedure (IRP), which […]

ePIL updates in the UK and EU

ePIL plans are progressing in both the UK and the EU. The aim is to make medicines information easier to access and easier to use, while also helping to reduce paper waste. But the message from regulators is still clear: paper leaflets are not going away any time soon. For now, digital information is being […]

Ex-regulator tips for streamlining your dossier

I still vividly remember my days at the MHRA – reviewing countless dossiers, applications, and cover letters under tight timelines. Sifting through complex justifications, tables, and supporting data to reach a final decision was not always easy. Each application was scrutinised to ensure that public health was protected, while also enabling Marketing Authorisation Holders (MAHs) […]