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 provides dossier publishing, regulatory operations, eCTD Publishing and eSubmissions services for human and veterinary drugs across multiple regions: EU, UK, US, Canada, Switzerland, GCC, and more.

For electronic dossiers, like eCTDs, our experienced e-regulatory specialists work with the latest software and our project managers use our 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 all types of dossiers. If needed, we liaise with agencies and overcome all potential hurdles, making Asphalion your partner of choice for even the most challenging regulatory submissions.

Asphalion provides dossier publishing, regulatory operations, eCTD Publishing and eSubmissions services for human and veterinary drugs across multiple regions: EU, UK, US, Canada, Switzerland, GCC, and more.

For electronic dossiers, like eCTDs, our experienced e-regulatory specialists work with the latest software and our project managers use our 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 all types of dossiers. If needed, we liaise with agencies and overcome all potential hurdles, making Asphalion your partner of choice for even the most challenging regulatory submissions.

Our Solutions

We can assist you in:

  • Conversion from paper submissions to eCTD format
  • Comprehensive eCTD services (defining eCTD granularity, submission readiness assessment, including quality check, eCTD readiness review and gap analysis, etc.)
  • Document formatting
  • Preparing eCTD submission-ready Clinical Study Reports
  • eCTD compilation and publishing
  • Validation and quality control of the eCTD sequence.
  • Submission of eCTD using Agencies’ gateways and portals
  • Project management and timeline for the publishing process
  • Full life-cycle support for Europe, USA, Canada, Switzerland, Saudi Arabia, GCC, and more
  • Software installation, training, validation and support
  • Translation Management for Centralised Procedures​
  • e-Regulatory specialists’ implant

 

Type of regulatory documents published and submitted:

  • EU (I): NP (National Procedure), DCP (Decentralised Procedure), MRP (Mutual Recognition Procedure), CP (Centralised Procedure), ASMF (Active Substance Master File), CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia), etc.
  • EU (II): IMPD (Investigational Medicinal Product Dossier), CTA (Clinical Trial Application), PIP (Paediatric Investigation Plan), etc.
  • UK: CP Grandfathering, ECDRP (European Commission Decision Reliance Procedure), etc.
  • US: DMF (Drug Master File), VMF (Veterinary Master Files), IND (Investigational New Drug), NDA (New Drug Application), ANDA (Abbreviated New Drug Application), BLA (Biologics License Application), SPL (Structured Product Labeling), etc.
  • CA: MF (Master File), Pharmaceuticals, NeeO (Non-eCTD Electronic-Only Format), etc.
  • GCC: National Procedures, Centralized Procedures

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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 offer eCTD services since 2008 and nowadays managed over 4.500 eCTD sequences per year. Our eCTD publishing and submission track record includes multiple CPs (20+), as well as submissions to FDA (200+), Health Canada (40+), GCC authorities (30+), etc. We have gathered over 50 clients in the eSubmission publishing tools, managing their tool maintenance: installation, validation, training and more.

Main benefits

  • 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
  • Use Asphalion as a “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”

For further information

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