(eCTD) Publishing and submission management
Your partner in Regulatory Operations
The process of eCTD publishing and submission requires a special skill and tool set… and a comprehensive understanding of the purpose of a dossier combined with future vision. Qdossier offers all of that through its qualified team members and standardized procedures; mostly remotely (inshore or offshore) and onsite when needed.
Submission management services
Qdossier can take over the following tasks; either temporarily or for an indefinite time.
- eCTD publishing and submission by compiling technically valid eCTD dossiers and submissions, such as:
- Initial EU MAA submissions following the Centralized Procedure, Mutual Recognition (MRP) or Decentralised (DCP) procedure, or National Procedure
- US IND, US BLA and US NDA submissions for the FDA
- Inclusion of US FDA datasets; SEND, ADAM, SDTM and/or BIMO datasets
- Use of Study Tagging Files (STF) within Module 4 and Module 5
- Publishing and inclusion of Case Report Forms (CRF publishing)
- AdPromo submissions
- Initial Canadian NDS submissions for Health Canada
- Initial Swiss submissions for Swissmedic
- Master Files such as ASMF and various types of DMFs
- Life cycle submissions like variations, amendments, commitments, renewals, PSUR and annual submissions
- Our team is experienced with
- Analyses and recommendations on solving perceived technical validation issues
- Hosting dossiers for client’s review via Qdossier’s Dossplorer™, or client platform
- Dispatch of the dossier to agencies worldwide using Qdossier’s own accounts on the submission portal (incl. FDA, EMA, Health Canada, SwissMedic and other National agencies)
- Coordination with regulatory agencies on technical issues related to eCTD submissions
- Help to setup a connection for electronic gateway submissions (depending on the region)
- Planning and definition of document granularity and document naming
- Guidance on cross reference strategy and hyperlinking strategy
- Efficient publishing of regulatory documents to submission readiness
- Interim management of Regulatory Operations Group
- Migration of dossiers from one system to another
- Reformatting and baseline submissions
The benefits of electronic submissions
‘The proof is in the pudding’ implies that you should take my word for it, or you could go through all of the evidence yourself. The latter is the necessary evil.
Regulatory dossiers contain the proof of the favorable benefit-risk ratio of a medicinal products for defined patient populations when used according to the product information. It also contains the proof that the product can be produced with a consistent high quality, safeguarding the patients.
Paper dossiers – though still being used in the majority of countries worldwide – are time‑consuming, costly and not transparent over time. Electronic dossiers are less time consuming, less costly and transparent over time, provided that it is implemented as electronic processes. These electronic processes should be instead of paper processes, not on top of… Electronic dossiers (as ICH eCTDs) are a commodity in WHO reference countries and embraced in more and more countries. When lifecycle is applied correctly during eCTD publishing and submission, it offers full transparency of what has been submitted when and for what purpose. It allows to associate additional data to the dossiers, to track agency responses, including approvals and commitments.
In June 2017, we decided to migrate to Qdossier for eCTD publishing: one of the most fructuous RA team decisions we could have made! Since then our eCTD submissions went through smoothly and in time! In addition, Qdossier performed several complicated eCTD reformatting operations to correct historic eCTD publishing errors. Qdossier does not behave as a regular eCTD publishing service provider, but instead is a full sparring partner with eCTD expert advice, who can troubleshoot and liaise with Competent Authorities on technical matters if needed. Short response times, easy to contact and informal. A relief and real pleasure to work with!