Lundbeck achieves first eCTD submission with Datafarm's eCTD solution.

When they were looking for a partner to help them achieve their first ever eCTD submission,
scheduled for January 2007, H Lundbeck A/S needed a product to meet its technical and
regulatory requirements and a vendor who had the expertise to help it install, train, validate
and prepare the system.

H Lundbeck A/S, the international pharmaceutical company specialising in drugs for the
treatment of psychiatric and neurological disorders, is one of the leading companies in its
field. As such, it wanted to adopt the most modern and efficient methods for its regulatory
submissions in advance of the statutory requirement due in 2009.

The company issued a Request for Proposal (RFP) in April 2006 for a complete electronic
submission solution that would meet its exacting technical and regulatory requirements,
enabling compilation/creation, management and viewing of eCTD submissions. The chosen
system had to be fully capable of delivering an eCTD submission scheduled for completion in
January 2007.

Lundbeck needed a vendor experienced in delivering eCTDs and with the expertise to help
the company achieve a successful transition to eSubmissions. The vendor needed to be
capable of supporting the system and to demonstrate strong client / vendor partnership
attributes to sustain a long term relationship.

Having considered proposals from four suppliers in a thorough and lengthy process,
Lundbeck chose to partner with Datafarm in late October 2006.

Combining its eCTDBuilder, eCTDViewer, Gatekeeper, pCTD, a-Pulse and Validation Kit
modules into one integrated solution to deliver the eCTD, Datafarm was also tasked with
implementation planning, implementation and integration services, training, SOP
considerations and validation assistance for Lundbeck.

Project managed by Lundbeck, the Datafarm team integrated with the Lundbeck project team
to provide technical and regulatory support.

They used the eCTDBuilder to build the XML backbone that constituted the electronic CTD
without the need for Lundbeck users to understand XML and eCTD Document Type Definition
(DTD). Its built-in intelligence made the creation of the electronic CTD submission seamless,
reliable and accurate.

The Lundbeck team was able to view and comment on the contents of the application
throughout its life cycle using Datafarm’s eCTDViewer and Gatekeeper validation module.
Gatekeeper verified the validity and integrity of the submission and, as an integral part of the
eCTD review process, allowed Lundbeck to mimic the agency review environment for its own
QA/QC process before the submission was shipped to the agency.

But just as important were the associated publishing requirements that supported and
streamlined the actual eSubmission compilation process. The Lundbeck eSubmission
benefited from having compliant and submission-ready source content (PDF) provided by the
a-Pulse automated PDF publishing solution.

A set of Adobe® Acrobat® plug-ins that focus on providing publishing automation combined
with intuitive maintenance and task management functions for eSubmissions, a-Pulse
provided Lundbeck with PDF publishing functionalities and navigational tools not available in
Acrobat®, making the PDF publishing process easier, quicker and more accurate.
And finally, as some agencies still require paper as the official and archival format, Lundbeck
used Datafarm’s pCTD (paper CTD) module to create a paper dossier from the electronic
CTD.

Datafarm helped Lundbeck go from purchase to production in less than eight working weeks; the
company’s first eSubmission was made on time in January 2007.

According to Steen Otto Rugaard, Project Manager for Lundbeck, Datafarm was chosen
because of the responsiveness of its people, from sales right through to support, “We were
very impressed by Datafarm’s positive, constructive interaction with our team, alongside its
obvious knowledge, expertise and understanding of the eCTD”, he explained. “Datafarm
clearly understands our business needs as well as our technical requirements.”

“Its regulatory understanding, attention to our needs, technical competence and
communication skills have all contributed to an excellent achievement for our company.”

“Without Datafarm’s fast responses we would not have been able to achieve this goal.”