eCTD Compilation

Our experienced team will assist you with your Operational eSubmission tasks. We will guide you through the eSubmission guideline jungle, and ensure that your valid submission will be delivered on time to the authorities. We can also offer to support and/or participate in agency meetings and discussions regarding your eCTD.

Submissions can be delivered in any format: electronically with XML (eCTD), NeeS, volumised PDF(s), paper or hybrids according to client and relevant health authority requirements. Our track record demonstrates the ability to understand the unique compliance issues associated with each dossier format and we always deliver an end product that meets and often exceeds our client's expectations.

Our main activities

  • Compilation of eSubmissions
  • eSubmission lifecycle management
  • Validation of eSubmissions
  • Consultation on eSubmission and regional guidances
  • Creation of paper dossiers
  • Scanning services

Experience

At PeC we have compiled eSubmissions in the following procedures:

  • EU: Centralised Procedures (CP), Decentralised Procedures (DCP), Mutual Recognition Procedures (MRP) and National Procedures (NP), including submission types such as: Initial Marketing Authorisation Applications, Baselines (Reformat), Variations (including submission modes grouped and/or worksharing), Supplemental Information(s), PSURs, FUMs, SOs, Renewals, Transfers, Line-extensions, Article 61(3) and ASMF
  • CH: National Applications, New Active Substances (NA-NAS), New Galenic Form (Na-NGF), Initial Marketing Authorisation Application, Reformat, Variation requiring authorisation incl. scientific review
  • US: New Drug Applications (NDA), Biologic License Applications (BLA), Abbreviated New Drug Applications (ANDA), Investigational New drug Applications (IND), including submission types such as: Original Applications, Amendments, Resubmissions, Annual Reports, Other(s), Chemistry Manufacturing Controls Supplement, DMFs, Arbitrations and Withdrawals
  • CA: New drug Application (NDA) and test application
  • RoW: Argentina, Italy, Mexico, Venezuela, Russia, Israel and Australia

All of these procedures have been maintained with life cycling in our validated system, and we allow our clients access to a complete overview of their submission(s) via. our secure WebViewer.

Please contact us at contact@pec-services.com to learn how Pharmaceutical eConsulting can start helping you today and in the future.