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Regulatory Operations: eCTD Publishing and eSubmissions

Highest efficiency in electronic regulatory publishing and submissions by using the latest tools and applying sophisticated project management

Regulatory Operations: eCTD Publishing and eSubmissions

Asphalion has its own regulatory operations team. Many pharmaceutical companies across the globe rely their publishing activities on our team, which offers multidisciplinary skills and services and embrace a different bunch of services like publishing activities in different formats.

Our experienced regulatory specialists work with the latest software using self-developed project management tools to guarantee compliance with critical submission timelines.

Many of our regulatory experts have decades of experience providing support for all types of regulatory procedures and types of dossiers. Our team collaborates regularly with Health Authorities, industry experts and EMA (European Medicines Agency) SMEs (Subject Matter Experts), making Asphalion your ideal partner for the most challenging regulatory submissions.

Regulatory Operations: eCTD Publishing and eSubmissions Solutions

Our services:

Boost your company health authorities approvals with the help of Asphalion’s Regulatory operations team. This is a comprehensive list of the publishing & submission related services that are most frequently demanded by our customers. If you have any other particular need, just let us know and we will manage it for you.

Moreover, Asphalion has a solid partnership with Extedo of more than 10 years, using their tools for publishing activities (e.g., eCTD Manager®, EURS Validator®) and providing customer support on their behalf for their regional clients.

  • eCTD/NeeS/ACTD/NeeO and other formats Compilation and Publishing
  • Comprehensive eCTD services (i.e. validation, quality control, defining CTD granularity, submission readiness assessment, gap analysis, etc.)
  • Preparing eCTD submission-ready Clinical Study Reports
  • Electronic Submissions using agencies gateways and portals (i.e. CESP, EMA Gateway, FDA ESG, MHRA Submissions Portal, etc.)
  • Project Management for the publishing process
  • Full initial and life-cycle management support for EU, UK, US, CA, CH, GCC, AU, ZA, JO, ASEAN and more
  • FDA SPL (Structured Product Labeling) services for prescribing information, GDUFA Self-ID, Drug Listings, etc.
  • Preparation of FDA SDF (Structure-Data Files) in .sdf file format
  • In-house creation of Simplified TS (Trial Summary) Datasets in .xpt format and Full TS datasets with our partner Cros NT

Publish submission-ready documentation more quickly with Asphalion’s expertise. This is a comprehensive list of formatting related services that are most frequently demanded by our customers. If you have any other particular need, just let us know and we will manage it for you.

  • Word files formatting (i.e. hyperlinks, bookmarks, ToC, etc.)
  • PDF files formatting and validation adapting to ICH and regional requirements (i.e. embedding fonts, versioning, etc.)
  • Preparation of customizable and compliant dossier templates (i.e. FDA NDA templates, etc.)
  • CTD file naming convention adaptation to regional requirements
  • PDF compliant formatting of Product Information for Centralised Procedures (i.e. metadata, bookmarking, etc.)
  • Project Management of Linguistics Translations with our trusted partner

Implement regulatory affairs software right from the beginning wit our experise. This is a comprehensive list of software related services that are most frequently demanded by our customers. If you have any other particular need, just let us know and we will manage it for you.

  • Publishing software installations, updates and customized configuration
  • Health Authorities Attributes updates (i.e. FDA, TGA, wtc.)
  • Dossiers Databases Migrations into new servers (on-premise or on-cloud)
  • Publishing software System Validation (i.e. IQ, OP, PQ)
  • Technical issues resolution (i.e. warnings, errors, validation reports, Health authorities deficiencies, etc.)
  • IT trainings related to publishing software (only available for Extedo tools)
  • Dossier Database Audits ensuring eCTD lifecycle is accuracy

We offer training courses on eSubmissions and Publishing with Extedo’s tools eCTDManager, EURSValidator and eSUBManager.

The content and duration are fully adaptable to the client’s needs and to the users’ knowledge level.

The training is delivered by experts in the area and includes the deliverables of the training material (i.e., manuals, guidelines, presentations, etc.) and the issuance of a training certificate.

The training methodology is mainly online, although it can also be carried out in person, as per your request. Training sessions are interactive and can be delivered both in Spanish and English, and the number of online attendees is unlimited. Additionally, a training server can be enabled for the attendees to carry out real practical cases.

This is a comprehensive list of the most demanded training topics:

 

eCTD Trainings

Increase your productivity and reduce cost with the expertise of Asphalion’s Regulatory Operations consulting team.

  • Implant of Asphalion’s employees in your company
  • Regulatory Operations Consulting (i.e submission strategy, dossier organization, document management, etc.)
  • Customer Support for Publishing software
  • Resolutions of technical issues (i.e. warnings, errors, validation reports, Health authorities deficiencies, etc.)

Customize your Regulatory Intelligence (RI) database by subscribing to Asphalion’s Regulatory Operations newsletter, helping you to avoid resource-intensive process of gathering regulatory information:

  • Monitoring of changes through newsletters
  • Customize your newsletter by content, region, procedure, etc.
  • Be notified when new content is available
  • Get instant access to authorities’ regulatory insights for informed decision making

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Why Asphalion?

At Asphalion, we have been at the forefront of electronic submission of regulatory information since the introduction of eCTD.

As a result of our flexible support and dedicated project management, we can produce high quality submissions within critical timelines.

We have been offering eCTD services since 2008 and, nowadays, we manage over 1,500 eCTD sequences per year.

Our ISO 9001 certification ensures traceability and secured storing.

 

  • Rely on regulatory experts to create your Publishing Plan
  • Get specialized eSubmissions expertise
  • Outsource time-consuming tasks
  • Succeed with ambitious submission timelines thanks to Asphalion’s project management
  • Asphalion: your “one-stop shop” for your eCTD submissions
Vicente Tur - Asphalion
Vicente Tur
Regulatory Affairs Director
“Asphalion has been at the forefront of eCTD, publishing and submission since the electronic format implementation began, so that we have been able to develop our expertise in multiple regions, in all types of regulatory processes and in all types of dossiers”
“Asphalion team offers flexibility in a highly evolving regulated environment using the latest tools and capabilities, providing high-quality publishing expertise across the globe for the full spectrum of pharmaceutical products”
Daniel Langa
Daniel Langa
Regulatory Affairs Associate Director European Medicines Agency SME

Related Resources

FDA FAERS

Here is an updated summary of the FAERS electronic submission.

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