In this white paper you will discover useful tips and advices dedicated to American biopharmaceutical companies interested in expanding or currently expanding in Europe with the intention of launching medicinal products on the European market.
In this white paper you will learn: Basic EU legislation for medicinal products Legal basis of the application in the EU Hybrid applications How to present your Hybrid application Timetable for Hybrid applications under Article 10(3) of Directive 2001/83/EC…
An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing a French Early Access Program for its orphan drug. PharmaBlue support them for the whole process of submission (advice, writing…
Our client a global pharmaceutical and biotechnology company specialising in the research, development and marketing of medicines and vaccines for immunology, oncology, cardiology endocrinology and neurology, asked BlueReg to publish and submit a Marketing Authorisation Holder transfer to ANSM for…
Two pharmaceutical companies sought solutions for review of promotional and non-promotional materials to ensure compliance with the European Union (EU) and national country legislation and guidelines for medicinal products. The objective for BlueReg was to provide provide a sustainable,…