Your Partner in Regulatory Operations and Tackling Global Submissions

Life sciences companies face a host of operational challenges with managing global regulatory affairs submissions. These include meeting complex timelines, fluctuation in submission volume throughout the year, variations in requirements from region to region, and the complexity of gathering data from different functions and from affiliates. In addition, companies must deal with the logistical challenges of managing IT tools and systems, many of which don’t provide an end-to-end view of the submission process.

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. Celegence offers all of that through its qualified team members and standardized procedures; mostly remotely (onshore or offshore) and onsite when needed.

Celegence: a Global Perspective to Submission Publishing

Celegence provides dossier submission services worldwide, supporting both eCTD and Non-eCTD electronic submissions [NeeS] formats. All submission services are supported by our experienced regulatory intelligence team, whose deep knowledge of local and regional guidelines ensure the provision of compliant and efficient regulatory publishing services. We can help streamline your end-to-end submissions management process, from dossier development to health authority interactions.

Our eCTD publishing services and document level publishing expertise take the complexity out of commonly experienced problems, such as formatting and hyperlinking issues, floating sections, and error corrections.

The Benefits of Electronic Submissions

Regulatory dossiers contain the proof of the favorable benefit-risk ratio of a medicinal product for defined patient populations when used according to the product information. Also, it 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 used instead of paper processes, not on top of them. 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 us to associate additional data to the dossiers, to track agency responses, including approvals and commitments.

Hosted Electronic Submission Management Platform

Source Document Management

Celegence offers hosted electronic submissions and services using our in-house publishing platform. We use this platform ourselves for the preparation of eCTD, non-eCTD electronic submissions and other dossier formats, but our customers can also view and/or review these through Dossplorer™.

Global Publishing & Validation

In-house, Celegence uses two of the major eCTD software tools, namely Lorenz Docubridge® and Extedo eCTDmanager™.

We can compile, validate, host and maintain eCTDs, non-eCTD electronic submissions, NeeS and ASEAN-CTDs for all countries worldwide, for all companies worldwide on our in-house publishing platform for hosted electronic submissions and services.

Dossplorer™ Regulatory Dossier Viewer

Once published, customers can access their dossiers via Dossplorer™.  Dossplorer™ allows you to share, compare, view and review eCTD, NeeS and other dossier formats from any region. The hybrid cloud/ on premise solution offers cloud-based software as a service whilst keeping your data privately stored on premise (either at your company or at Celegence’s in-house publishing platform for hosted electronic submissions and services).

We can fulfill the role of dossier- and business administrators for your company and take care of the recordings of your dossiers in Dossplorer™ and manage the user administration.

eCTD Viewer Software - Dossplorer Technology
More Info

Celegence’s Publishing & Submissions Services Include:

  • Dossier submission services to multiple health authorities
  • Paper to NeeS to eCTD conversions in keeping with health authority formats worldwide
  • Regulatory intelligence services to interpret regional and national requirements for submissions
  • Comprehensive quality check and adherence to predefined SLAs
  • Extension of the in-house publishing team and management of the submission tools with Business Process as a Service (BPaaS) model

  • End to end services for Publishing, Submission and Archival of Dossiers for multiple regions

  • Management and Submission of IND Safety & Adverse Event Reports

  • Document Formatting and Publishing – Word Style Guides and PDF Navigation

  • 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)
  • Ad Promo 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, PSURs and annual submissions

Our team is experienced with:

1.

All major eCTD software tools, including Lorenz Docubridge®, Extedo eCTDmanager™, Liquent Insight® Publisher, and Amplexor myPharmaExpert™

2.

All major document management systems, including and not limited to Amplexor myPharmaExpert™, Documentum®, Livelink®, SharePoint® and Veeva Vault

3.

Analyses and recommendations on solving perceived technical validation issues

4.

Hosting dossiers for client’s review via Dossplorer™, or client platform

5.

Dispatch of the dossier to agencies worldwide using Celegence’s own accounts on the submission portal (incl. FDA, EMA, Health Canada, Swissmedic and other National agencies)

6.

Coordination with regulatory agencies on technical issues related to eCTD submissions

7.

Help to set up a connection for electronic gateway submissions (depending on the region)

8.

Planning and definition of document granularity and document naming

9.

Guidance on cross reference strategy and hyperlinking strategy

10.

Efficient publishing of regulatory documents to submission readiness

11.

Interim management of Regulatory Operations Group

12.

Migration of dossiers from one system to another and reformatting and baseline submissions

Additional Information

Download the latest brochure of our capabilities and services.

DOWNLOAD PHARMACEUTICAL BROCHURE
Pharmaceutical Industry Regulatory Affairs - Celegence

Contact Us

If you’re curious how Celegence can help with your Publishing & eCTD
needs, reach out to us and one of our team members will get in touch with you.

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