Ectd Leaflet Euphar

Projekt2

26.9.2008

10:08

Stránka 1

We are ready offer to you with any other services: Regulatory Affairs  Readability User Testing  Comparison of SmPC for MRP  European regulatory strategy  Labelling and Mock up  Marketing and Authorisation Applications – Decentralised and MRP as CMS or RMS, National procedure  Post-marketing activities – product maintenance – renewal, variation  Preparation of Module I according to the local requirements  Preparation of Module II  Reformatting the paper CTD dossier to the new eCTD

Do you need to submit your dossier in eCTD format on time? Then you need eCTD Prima® software! eCTD Prima® is a software product for the creation, viewing, manipulation and archiving of regulatory dossier by pharmaceutical companies to the regulatory authorities. eCTD Prima® has everything what you need to satisfy requirements for submission to multi-region agencies. Only 1-3 days training – easy to understand and to start working immediately.

Pricing and reimbursement strategy  Pricing assessment  Public policy assessment  Reimbursement negotiation strategy Our software to your success Headquarter: Euphar s.r.o. Zlíchovská 193/5 143 00, Prague 4 Czech Republic

Office: Euphar s.r.o. Ke Schodům 1397/20 143 00, Prague 4 Czech Republic

Contact: www.euphar.cz mobile: +420 731 16 99 14 tel./fax: +420 241 40 31 73 email: [email protected]

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eCTD Prima® is attacking  chaos  complexity of documents  inefficiencies

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On line access anytime

You will know who and when files were changed.

eCTD Prima® eliminates IT and RA headache, error-prone processes that traditionally hinder program using (naming of files is in default paths).

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

Ask for the best solut ion use eCTD Prima ®

ed ganis g r o rima n namin P D eCT l mess i f files a a tot tructure o and s ®

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eCTD Prima® was developed based on ICH and EMEA requirements and fulfils criteria for xml submission but the design and features were built on the Regulatory Affairs knowledge and 11-year experience with submission of registration. This is the reason why our software is clear and easy to navigate.

26.9.2008

The main tasks of the program development were:  easy navigation and clear structure (mainly for MRP/DCP procedures)  smooth functioning with intuitive and friendly use interface.

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

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

Projekt2

Stránka 2