On 6-8 April Dossplorer will have a booth at the Global Pharmaceutical Regulatory Affairs Summit (GPRAS) in Berlin, Germany where you can see our solution and ask all of your questions. Also two of our Qdossier members (Hans van Bruggen and Marloes van der Geer) will be joining the conference and they would love to […]
Join us in an interactive two-day course that will provide you with a clear and comprehensive understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of the EU and USA. Furthermore, the course examines the requirements for global roll-out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories. You will increase your […]
Our CEO Hans van Bruggen will be attending the DIA Global Annual Meeting, taking place in Chicago this year. If you want to know about our services and how we can help you navigate through complex challenges of regulatory affairs/operations, please reach out via info@qdossier.com and we will make sure to connect.
On June 20th, Qdossier will present a 1-day training course which is part of the Management Forum training curriculum. The interactive course will cover all the key aspects of orphan drug legislation in both the US and EU and the regulatory strategies/processes designed to enable early access to innovative medicines. During this training you will: […]
On June 27 and 28th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The interactive course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. During this training […]
On July 7 and 8th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The 2-day event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. During this training you […]
On September 26th, Qdossier will present a 1-day training course which is part of the Management Forum training curriculum. The interactive course will cover all the key aspects of orphan drug legislation in both the US and EU and the regulatory strategies/processes designed to enable early access to innovative medicines. During this training you will: […]
On October 10 and 11th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The interactive course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. During this training […]
On October 11 and 12th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The interactive course will cover the regulatory pathways and challenges for biosimilars in both the US and EU and the regulatory strategies and requirements for development of biosimilar products. During this training you will: Discuss global […]
On October 13 and 14th, Qdossier will present a 2-day training course which is part of the Management Forum training curriculum. The 2-day event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. During this training you […]
