Let us help your organisation benefit from

1

Let us help your organisation benefit
from eCTD Electronic Publishing Services at
the NDA Group www.ndareg.com  
2
eCTD Improving Decision Making Processes for
Medicinal Products within the European Union The
NDA Group has gained a reputation as an
outstanding regulatory consultancy dedicated to
secure our clients investments in their products
and striving to ensure rapid access to the market
and optimal life cycle management. Rapid access
to the market, however, is not merely dependent
on document content but also on the highest
standard of presentation allowing efficient
review by regulatory agency assessors. This is a
common goal shared by industry and regulatory
agencies. On 28th February 2005, the Heads of
Medicine Agencies (HMA) agreed that by the end of
2009 all agencies must have the infrastructure
and processes in place to handle electronic-only
eCTD to support related decision-making processes
for medicinal products within the European Union.
A major milestone on the road to achieving this
goal has already been met As of 1st July 2008,
the EMEA accepts electronic-only submissions
(eCTD or NeeS) for Marketing Authorisation
Applications under the Centralised Procedure.
While this presents a great opportunity for the
pharmaceutical industry it may also pose a
hurdle to companies. For those organisations
that have little experience with regulatory
requirements around electronic submissions (eCTD
or NeeS), limited technical infrastructure or
insufficient resources to prepare eCTD compliant
submissions, NDA offers tailor-made electronic
publishing services using the worlds leading
publishing tool docuBridge .
3

• Our Electronic Publishing Services
• Preparation and compilation of eCTD Marketing
  Authorisation Applications for submission under
  the Centralised Procedure, Decentralised
  Procedure and Mutual Recognition Procedure
• Conversion of existing dossiers into eCTD
  compliant dossiers
• Preparation and compilation of Non-eCTD
  electronic submissions (NeeS) submissions (MAA
  dossiers, Clinical Trial Applications,
  Investigational Medicinal Product Dossiers,
  Clinical Study Reports)
• Template development and document preparation
• Document repair (styles / resizing / cleaning /
  splitting )
• Pdf conversion including Optical Character
  Recognition (OCR)
• Our Commitment
• NDAs regulatory experts together with a
  dedicated electronic publishing team with
  extensive experience in electronic publishing
  will aid you in the preparation of eCTD compliant
  documentation of the highest possible quality
  standard ensuring that your product will reach
  the market in the shortest time possible.
• Your Benefit
• Reduce your costs by avoiding duplicate paper
  submissions
• Reduce resource requirements
• Speed-up timeline to submission
• Improve document review
• Easier submission maintenance / Life-Cycle
  Management
• Reduce requirements on archiving space

4
For further information please contact Debra
Powell Tel. [phone]
4000 E-Mail Munich_at_ndareg.com NDA
Regulatory Service GmbH Weihenstephaner Strasse
28 D - 81673 München Germany Liz Platts Tel.
44 (0) 1372 860 610 E-Mail
ukoffice_at_ndareg.com NDA Regulatory Science
Ltd. Prime House, Challenge Court Barnett Wood
Lane Leatherhead Surrey KT22 7DE United
Kingdom Anna Johnson Tel. [phone]
E-Mail office_at_ndareg.com NDA Regulatory
Service AB Johanneslundsvägen 2 Oxfordhuset
SE-194 81 Upplands Väsby Sweden