- Consultancy
Strategy and procedures
- Services
- Solutions
Dossplorer regulatory dossier viewer
Submission document templates and content plan
- Customers & Cases
History
Since January 2006
In January 2006, eCTDconsultancy (now Qdossier consultancy) was founded. Not long after that, Qdossier (now Qdossier services) was established. Since then Qdossier has grown to a team of specialists with a wealth of experience in regulatory affairs and electronic submissions, specializing in right-first-time eCTD lifecycle management and regulatory information management.
A solid reputation
Qdossier has built up a solid reputation within the pharmaceutical arena. Our employees are respected speakers at many regulatory congresses including DIA, IRISS, RAPS, and TOPRA events.
Leadership
Founder and CEO Hans van Bruggen has many years of practical experience in the pharmaceutical industry. His vision, drive and enthusiasm led to the successful submission and validation of the first eCTD for an initial Marketing Authorization Application worldwide for a new chemical entity and the first eCTD for the European centralised procedure in 2003. Today this expertise and enthusiasm is embedded in the culture of Qdossier and propagated by team members.
Qdossier solutions
In 2017, Qdoor B.V. was founded (now Qdossier solutions), a software company for life sciences. Qdossier solutions developed the Dossplorer™ regulatory dossier viewer. Our mission is to facilitate optimal re-usability and consistency in document management across regulatory dossiers by creating transparency.
