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AL MOUTAFAWIQA COMPANY IS A PARTNER OF RA UNIQUE

eCTD & NeeS

  • Common Technical Documents (CTD)
  • Non-eCTD electronic Submissions (NeeS and VNeeS)
  • Human and Veterinary Medicinal Products
  • EU, UK, Rest of World
  • Preparation of full dossiers for new product applications
  • Converting NeeS or paper dossiers into eCTD
  • Origination, compiling, publishing & validation

The electronic Common Technical Document (eCTD) is the mandatory format for presenting information for Human Medicinal Products to National Competent Authorities.

The NeeS format is still used by some Competent Authorities for National only submissions for Human Medicinal Products.

The VNeeS format is the mandatory format for presenting information for Veterinary Medicinal Products to National Competent Authorities.

At QP-Services UK Ltd we have the skills and software needed to originate, compile, publish and validate dossiers for submission to Competent Authorities in the UK and EU and Rest of World in the required eCTD/NeeS/VNeeS format.

We manage a wide range of products on behalf of our clients, from older dossiers (40+ years old) through to full five module recently approved authorisations.

We have been responsible for creating 50+ eCTD baselines, extracting data as needed from electronic and paper files, publishing sequence 0000 and notifying relevant Competent Authorities.

We can adapt to your requirements as needed:

  • Simple publishing of variations prepared by you
  • Checking of your documentation prior to compiling
  • The origination of full dossiers for new Marketing Authorisation Applications from your raw data
  • Anything inbetween and much more…

The software we use is compatible with free eCTD/NeeS Viewer software so that you can view the published eCTD in the same format as the receiving Competent Authority, without the need to buy expensive software.

We can provide full training on using the eCTD/NeeS Viewer software and understanding how you can best manage the sequences/publications to ensure current information s readily available to all relevant parties including contract manufacturers, commercial and your quality teams.