Qdossier

Proper management of data, documents and dossiers saves the pharmaceutical industry and agency time and money. Qdossier takes complete ownership and is fully committed to create compliant submissions right first time. We understand the importance of technical- and business validation of regulatory dossiers. Our business knowledge, clear communication and approach towards information ensures that our sponsors can remain focused on their core business. We manage and implement eCTD, NEES, DMF, XEVMPD and IDMP across product types and countries, using sponsors tools or our own tools, remote or onsite. Looking forward to hear about your challenges so we can offer help...

Ectd,idmp,regulatory operations,module 3 baselines,brexit,regulatory information management,hosting,ectd viewing tool,document templates,lean authoring,structured content management,submission management,process development,data migration,document migration,dossier migration,due diligence,regulatory strategy,procedural support,cmc authoring,and medical writing

Qdossier operates in the Pharmaceutical manufacturing industry.

Qdossier's revenue is 11m - 100m

Qdossier has 11 - 50 employees.