eCTD

 

 LORENZ Life Sciences Group - docuBridge®

 LORENZ Life Sciences Group, active in the market since 1987, is also the market leader in Regulatory Affairs software and services. Initially LORENZ LSG has developed the pharmBridge® for German Health Authority (BfArM), as a part of DAMOS (Drug Application Methodology with Optical Storage) project, so that they became a pioneer in electronic submisson systems. Then, pharmBridge® has evolved into docuBridge® in time.

 LORENZ LSG is represented in Europe, North America and Asia through its branch offices and representatives like Frankfurt/GERMANY, Warsav/POLAND, Philedelphia/USA, Tokyo/JAPAN, Guildford/UK, Toronto/CANADA, Chennai/INDIA and ISTANBUL/TURKEY (MK Consultancy Training & Medicinal Products).

 docuBridge®, which is the product of LORENZ LSG, is evolved by 20 years of specific Regulatory Affairs experience and its success has been proved by this experience. It is the most advanced and the comprehensive document/submission management system.

 With a broad spectrum of customers in North America, Asia and Europe, docuBridge® is the only complete document/submission management system used by both industry and authorities.

 docuBridge® software package can be specifically designed and modified for all kind ans size of companies (originator, generics, biotec, import, export) and Authorities according to their needs, infrastructure, regulations that they are subjected to.

 With its adaptive arthitecture, which is provided by its unique design, docuBridge® can work under any kind of submission standart (NDA, CTD, eNDA, eCTD, etc) that was valid in the past, is valid now and will be valid in future.

 Right now, eCTD is the mandatory electronic format for FDA. It will also be mandatory in EMEA starting form 01 January 2010. Besides these, Health Canada prefers eCTD and Japan can accept eCTD. Morover, Germany, Aurtia, UK, Belgium, Spain, France, Netherlands, Czech Republic, Norway, Sweden and Hungary is accepting eCTD and other electronic submission types and Poland together with other EU member states will have to accept eCTD starting form 01 January 2010. Switzerland and Australian Health Authorities are also planning to accept eCTD starting from 01 January 2010.

 docuBridge®, which has over 160 installation over the world, is also used by Health Canada (Canadian Health Authority), BfArM (German Health Authority), AGES (Austrian Health Authority), JZAMP (Slovenian Health Authority) as a review tool for the submissions. FS (Russian Health Authority) has also signed a letter of intent to implement docuBridge® in 2009 to their system. Additionally, the discussions with the TGA (Autralian Health Authority) and Swiss Medic (Switzerland Health Authority) is still in progress.

 Health Canada has started to use docuBridge® in February 2006 and since then, more that 500 reviewers have been trained on and used docuBridge® for reviewing eCTDs and other electronic applications. Total 210 eCTD and 1080 follow-up procedures together with 2270 non-eCTD electronic application has been processed.

 BfArM is using docuBridge® since 2003. More that 500 reviewers have been trained on and used docuBridge® for reviewing eCTDs and other electronic applications. Total 800 eCTD and 6000 follow-up procedures together with 2000 non-eCTD electronic application has been processed. Also, more than 60.000 DAMOS submissions and scanned paper applications are still processed by using docuBridge® .

 AGES is also using docuBridge® since 2004. More that 50 reviewers have been trained on and used docuBridge® for reviewing eCTDs and other electronic applications. Total 61 eCTD and more that 1000 follow-up procedures together with 1970 non-eCTD electronic application has been processed. Also, more than 11.600 scanned paper applications are still processed by using docuBridge® .

 And JAZMP is using docuBridge® since 2002.

 Based on the experience gained by long term use by Industry and Authorities, it is concluded that by transitioning to eCTD and using docuBridge®, below listed benefits and advantages can be obtained.

        1.      More advance submission method

        2.      More effective submission review process

3.      More efficacy=less time to spend for reviewing

4.      Faster replies to the applicants

5.      End of paper application time and the end of resulting financial load and the workload