Project Orbis
Download our white paper dedicated to Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.
BlueReg Group Drug Registration
Download our white paper dedicated to Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.
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…
Background: In February 2022, the EMA initiated the establishment of the Coordination Centre for the Data Analysis and Real-World Interrogation network (DARWIN EU®). In this context, EMA has organised a multi-stakeholder information webinar to: introduce DARWIN EU and…
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…
BlueReg was involved in the review of a Hybrid Application for a medicinal product in Ophthalmology to be submitted to the European Medicines Agency (EMA). BlueReg reviewed the Module 3 (Quality) as well as the Quality Overall Summary (QOS), Non-Clinical Overview…