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 and 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 is also 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 accept eCTD starting form 01 January 2010. Australian Health Authority is planning on moving to the eCTD starting next year. Saudi Arabia has released its eCTD specifications and plans to start accepting eCTDs by January 2014. Additionally, South Africa has also announced that it will move to the eCTD starting in mid-2014. It is planning on conducting a pilot project starting in June 2013 to give the pharmaceutical industry the opportunity to sumbit test eCTDs.

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.

Latest News

Recently, the EU has made changes to their eCTD specifications and LORENZ had made available an update to its customers.

docuBridge, the leading Submission Management Solution on the market, has recently been updated to version 5.2 SP1. This new version, starting with version 5.0, has been completely redesigned, offers a lot more functionality, and is a lot more user-friendly as well. Some of the newest changes to the 5.2 SP1 software has been the addition of both the Saudi Arabia (GCC) eCTD and South Africa eCTD specifications.

RPS (Regulated Product Submission), a new format (some call it eCTD version 4.0), will start being tested at the US FDA this coming fall. RPS, a modified electronic format, will eventually be replacing the current eCTD format, and will enable an applicant from any industry: medical devices, pharma, biotech, etc…; to submit an RPS application to the US FDA.  Canada, Europe & Australia are also considering adopting the RPS format in the future.  docuBridge is already capable of publishing into the RPS format – many of our customers want to be able to take part in the RPS Pilot Project at the US FDA this coming fall.