Projekt2 26.9.

2008 10:08 Stránka 1

Do you need to submit your dossier

We are ready offer to you with any other services: in eCTD format on time?
Regulatory Affairs
 Readability User Testing Then you need eCTD Prima® software!
 Comparison of SmPC for MRP
 European regulatory strategy eCTD Prima® is a software product for the creation, viewing,
 Labelling and Mock up manipulation and archiving of regulatory dossier by pharmaceutical
 Marketing and Authorisation Applications – Decentralised companies to the regulatory authorities.
and MRP as CMS or RMS, National procedure
 Post-marketing activities – product maintenance – renewal, eCTD Prima® has everything what you need to satisfy requirements
variation for submission to multi-region agencies.
 Preparation of Module I according to the local requirements
 Preparation of Module II Only 1-3 days training – easy to understand and to start working
 Reformatting the paper CTD dossier to the new eCTD immediately.

Pricing and reimbursement strategy

 Pricing assessment
 Public policy assessment
 Reimbursement negotiation strategy

Our software to your success uick re

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and oftwa®
sy s
Headquarter: Office: Contact: Ea with ima
Euphar s.r.o. Euphar s.r.o. www.euphar.cz
ork P r
Zlíchovská 193/5 Ke Schodům 1397/20 mobile: +420 731 16 99 14 w TD
143 00, Prague 4 143 00, Prague 4 tel./fax: +420 241 40 31 73 eC
Czech Republic Czech Republic email: eCTD@euphar.cz

eCTD Prima® is attacking

 chaos
 complexity of documents
 inefficiencies
 Projekt2

The main function of the eCTD Prima® is the creation of the documentation in eCTD format.
26.9.2008

We synthesised IT background and RA knowledge by developing the software eCTD.

The main tasks of the program development were:

10:08

 easy navigation and clear structure (mainly for MRP/DCP procedures)

 smooth functioning with intuitive and friendly use interface.
Stránka 2

eCTD Prima® was developed based on ICH and

ed EMEA requirements and fulfils criteria for xml
o®r ganis g submission but the design and features were built
D P rima n namin on the Regulatory Affairs knowledge and 11-year
eCT l mess i
a f files experience with submission of registration. This is
a tot tructure o the reason why our software is clear and easy to
and s navigate.

Ask for the

best solut
use eCTD ion You will know who
Prima ®
and when files
were changed.

The benefits eCTD Prima®:

 improved dossier quality,
On line access anytime
 fast access to dossier for everyone who has access to electronic dossier,
 less paper quantity,
 good price for software  cost effectiveness,
cess).
 no limitation of access to software in company (only company policy can limit access).
 eCTD Prima® is built on eCTD architecture for all types of registration
processes: CP, MRP, DCP and NP

s you
® all
ow tep
m a siers
i
D Pr a dos gical n
eCT mpile ith lo igatio
o w av
to c y step tive n
b i
d intu
an

eCTD Prima® eliminates IT and RA headache, error-prone

processes that traditionally hinder program using (naming
of files is in default paths).