Pierre Fabre Laboratory is the 2nd largest independent
French pharmaceutical laboratory.

Two main branches
characterise the company:
“Pierre Fabre Medicament” and “Pierre Fabre
Dermo-Cosmetics”.
Pierre Fabre Medicament orients its development on specifi cally targeted therapeutic
lines. Its focus areas lie on Oncology, Cardiovascular/Metabolism, Central Nervous
System and Dermatology.

Challenge

Pierre Fabre has used a publishing tool in combination with Documentum® for
years and submitted dossiers to agencies worldwide since 1995.
In the context of eCTD requirements, Pierre Fabre decided to search for a new system
suitable to their eCTD submission needs. Pierre Fabre set up a project plan for
investigation, proof of concept, decision making, purchasing and implementation.
The time window for this project has been defi ned on purpose challenging. The
target was to build two eCTD submissions at latest six weeks after system installation
including the qualifi cations and training phase. The system should be installed
with an integration to Documentum®.

Solutions and results

EXTEDO’s eCTDmanager was Pierre Fabre’s first choice based on these requirements.
EXTEDO’s suite of e-Regulatory solutions can be used as a comprehensive solution
or as “building blocks”. eCTDmanager is a scalable, “all-in-one” electronic submission
management system for eCTD and other electronic and paper submissions.
eCTDmanager offers fl exibility and security in building, viewing, validating, publishing
and compiling electronic and paper submissions.

The conjunct team (Pierre Fabre and EXTEDO) achieved the given challenges.
Four weeks after the implementation of eCTDmanager, including data migration
from the existing publishing tool, two submissions have been successfully forwarded
to the authorities. As of today fifteen submissions have been successfully produced.

“The eCTDmanager, EXTEDO’s proprietary solution for the complete preparation
of eCTD and paper submissions, creates also the opportunity to optimize the
process for publishing with a real benefi t on time, cost and life cycle
management of the dossier,”
explained PF publishing team manager.

EXTEDO’s EURS is Yours solution created additional synergies and benefits for
Pierre Fabre. EURS is Yours, a multifunctional software solution that serves as an
overall eCTD validation, retrieval, view and review software, saves time as it provides
a detailed report on whether a submitted eCTD-based application conforms with
the offi cial interpretation of the eCTD format.

“For Pierre Fabre this is a real advantage to have the same view as the
authorities, which is key for agency communication procedures,”
added PF publishing team manager.

Specifically designed for the validation, acceptance, import, view, review and
maintenance requirements of the EMA and associated National Competent
Authorities, EURS is Yours is today used from the industry as well.

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