Meda Pharma GmbH & Co. KG, the German subsidiary
of the leading Swedish pharmaceutical company
Meda, provides a large spectrum of both prescription
and over the counter drugs to the German market.

Its focus areas for the German market lie on therapies
for respiratory and dermatological diseases, on the cardio-vascular and central
nervous system plus pain.

Challenge

“As already 1995 the company has started to administer all regulatory documents
using an EDMS (Documentum®) it was quite logical that based on our document
repository we tried to profit by the regulatory innovation called eCTD as soon as
possible.

“The strategy was to extend our advantage resulting from the early EDMS use
via electronic dossier creation. We were sure to benefit regarding submission
transparency and archiving issues, aspects which in the long run have an impact
on resources,” explained Jaroslava Paraskevova, Head of Documentation and Information Services
of Meda Pharma.

“2005 after a careful market examination and a subsequent pilot project including
test installations of 2 eCTD tools we selected eCTDmanager. The system convinced
by high score superiority in the testing and the best fi tting to our needs.”

Solutions and results

EXTEDO’s suite of e-Regulatory solutions can be used as a comprehensive solution
or as “building blocks”. eCTDmanager, EXTEDO’s scalable, “all-in-one” electronic
submission management system for both eCTD and other electronic and paper
submissions, is used as a key building block in many pharmaceutical companies
such as Meda Pharma. The tool offers both fl exibility and security in building,
viewing, validating, publishing and compiling electronic and paper submissions.
With products sold in approximately 120 countries this software offers Meda
Pharma concrete advantages, creating benefi ts such as time and cost savings.
In addition a very important aspect is a significant improvement concerning
the regulatory control and transparency of product lifecycle. Beyond that a local
eCTDmanager use (several EU countries) facilitates a better co-operation with
affi liates and more effi ciency in DCP and MRP submissions.

“All things considered eCTDmanager proves to be the key tool regarding our
cross-national regulatory co-operation in Europe. Corresponding to the long-run
strategy of Meda Pharma to involve all local affi liates in a centralized eCTDmanager
use we expect further substantial benefits,”
underlined Jaroslava Paraskevova.

Dedicated to increasing efficiency, MedaPharma decided to also employ the
eCTDmanager Suite option RLPmanager. RLPmanager primarily supports clinical
departments for pre-publishing work such as studies or reports. Using eCTDmanager
and RLPmanager in an integrated environment enables the highest level of efficiency.
Available reports or studies including inter- and intra document hyperlinks can easily
be “dragged and dropped” from RLPmanager into eCTDmanager and reused for
different purposes. Using the integrated check for the new reports/studies easily
facilitates changes to the reports or studies during the lifecycle.

EXTEDO’s EURS is Yours solution created additional synergies and benefi ts for
Meda Pharma. 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.

“Particularly valuable is also the EURS is Yours solution which enabled us to
establish a very efficient validation process for our eCTD dossiers prior to
submission to the authorities. A speedy powerful control using an assessor-like review is extremely helpful
during the short timeframe between the dossier fi nalization and the offi cial
submission date. Such fi nal check is rather important as it prevents from
technical rejection and this saves time and money.”

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. Especially to have the
same view as the authorities is key for agency communication procedures.

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