Qdossier B.V.

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Qdossier, lead by Hans van Bruggen, has a dedicated and growing team of specialists who are fully committed to the Company's slogan "First time right". Proper management of documents and dossiers saves the pharmaceutical industry and agency time and money. Qdossier takes complete ownership and is fully commited to create compliant submissions the First time right. We understand the importance of technical- and business validation. Our business knowledge, clear communication and flexible approach ensures our sponsors can remain focussed on their core business. Together with eCTDconsultancy we also actively share our experiences with industry and agency representatives to develop harmon

idmp ectd xevmpd eudravigilance controlled vocabulary evmpd ctd clinical data transparancy policy 0070 ema lean authoring cmc quality regulatory dossier module 3 regulatory information management thesaurus rim xevmp taxonomy esubmission ectd viewer electronic submissions ectd 4.0 ectd guidelines identification of medicinal products signal detection xevprm document templates qdossier context regulatory document management pharmacovigilance pbrer psur

Activity
About

Qdossier B.V.

Presentations

Building a link between ectd and xevmpd

How document templates can facilitate or prohibit multipurpose documents

Practical XEVMPD experience; once upon a time there was a perfectly clean database!

ISO IDMP: Practical considerations from XEVMPD experience

A decade of eCTD - Time to rejuvenate!

Mastering Controlled Vocabularies (CVs) to faciliate succesful Regulatory Information Management (RIM)

Lean authoring of module 3

Clinical data transparency - EMA Policy 0070