60 LORENZ Life Sciences News Feed List of all press releases issued by LORENZ. http://www.lorenz.cc <![CDATA[LORENZ and Sinapse form partnership Down Under]]>

Melbourne, Australia and Frankfurt/Main, Germany, 29 November 2017 // Sinapse Pty Ltd, a leading Australian-based management consulting, technology and systems integrator, and LORENZ Life Sciences Group, the market leader as the world’s preeminent supplier of e-Regulatory solutions, jointly announce a strategic partnership today.

”The partnership with Sinapse“, says Wolfgang Witzel, President of LORENZ Life Sciences Group, ”is a huge step to the other side of the world. Not only are they known throughout Australia and New Zealand, Sinapse also works with a number of pharmaceutical companies on a global scale on a number of projects. Partnering with Sinapse gives us the opportunity to work with a well respected and knowledgeable organization, through which their customers will benefit from immediately. With the Australian TGA already accepting eCTDs, and with the pharmaceutical industry looking for more ways to manage and oversee their regulatory information, this partnership just simply makes sense.”

Soula Skliros, a co-founder and Partner at Sinapse, sees the partnership as a way to give even more value to their current customer base in the pharmaceutical industry: “LORENZ is the market leader in providing e-Regulatory software products to the pharmaceutical industry. Their eCTD Submission Management Solution – docuBridge – used here at the Australian TGA and other government drug authorities like Canada’s Health Canada & the EU’s EDQM, is also well represented and implemented at hundreds of pharmaceutical companies around the globe. LORENZ offers a range of software products that enables a pharmaceutical company to more efficiently compile and manage their electronic submissions, but to also have a better overview of their entire regulatory information – something every company is striving to achieve“ .

 

About Sinapse Pty Ltd
Sinapse works with leading global health and pharmaceutical companies on their business strategy, business optimization and systems implementations. The depth of experience includes ERP and CRM implementations, Sales and Marketing, Retail and Hospital environments, Wholesale Distribution providers and originators and Generic Pharmaceutical companies.

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services.
Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base. (Version: August 2017)

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=229 Wed, 29 Nov 2017 00:11:00 +0000
<![CDATA[Registration is open for LORENZlink 2018 RIM Solutions Conference]]>

Philadelphia, November 21, 2017 // LORENZlink, LORENZ’s North American Regulatory Information Management Solutions Conference will take place during April 16-17, 2018 in Nashville, Tennessee at Gaylord Opryland Resort and Convention Center. While the first 2 days of the conference will feature presentations and tutorials held by a distinguished faculty of LORENZ customers, partners and employees, participants will have the option to stay on for a third day of docuBridge training if they so choose.

 

 

LORENZlink’s philosophy is to Converge, Connect and Collaborate, and as such many LORENZ customers and partners will share their own practical experiences and best practices relating to current hot topics, trends, products and services in regulatory affairs.

Registration for LORENZlink will be open beginning November 21st, 2017. To register please click here.

A preliminary agenda for the conference itself will be available on our website in December. We urge anyone who would like to register for the optional docuBridge training day to do so very soon as space is limited, and based on previous experience we expect the class to fill up before the end of the year.

“The LORENZlink conference and the docuBridge training day will give our customer base from industry, regulatory agencies and academia the opportunity to experience the rich exchange of ideas that LORENZ events are so well-known for in our industry,” said Yaprak Eisinger, MD North America, “and we look forward not just to learning from each other but also to enjoying what Nashville has to offer, from the Grand Old Opry to good old fashioned southern food and hospitality.”

If you are interested in becoming a speaker and/or tutorial leader or if you have questions related to LORENZlink 2018, please contact us.

 

 

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base. (Version: August 2017)

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=228 Tue, 21 Nov 2017 00:11:00 +0000
<![CDATA[Workshops in Cairo and San Diego underline LORENZ global expertise]]>

Frankfurt/Main, 26 October 2017 // LORENZ recently hosted a hands-on eCTD compilation workshop in Cairo with more than 20 participants drawn from the GCC and African markets. The event followed the Egypt Pharma Regulatory Conference, which ran from October 15th-17th.

Feedback from the workshop led by professional trainer Tim Ivanic, served to confirm that users see LORENZ docuBridge as a smooth, intuitive compilation and publishing solution that also offers unparalleled functionality. The wider Pharma Regulatory conference in Cairo focused on “Entering GCC and African markets,” and aimed to provide the pharmaceutical industry and software vendors with deeper market insight. Topics included pricing regulations in the two regions, regulatory changes, and the unique challenges of Africa and the Middle East from both an agency and industry perspective.

Networking discussions made one thing clear: “going eCTD” is on the industry’s mind now more than ever in both the Middle East and Africa, two regions which expect to tap into the experiences gained in other areas of the world.

During the same week in mid-October, halfway around the world in San Diego, California, LORENZ participated in two RAPS workshops; “Intermediate Course for Regulatory Submissions in eCTD Format;” which drew 45 participants for the hands-on programs. “We were very pleased with the level of depth that the workshops offered all participants,” said Elsmari Eggers, the Head of Training and Consulting at LORENZ Life Sciences Group.

A range of further workshops will be offered by LORENZ during November 2017:
• Nov 2nd, LORENZ docuBridge as Submission Management System (Part II) - Webinar
• Nov 6th, RAPS Workshop - Intermediate Course for DMF, ASMF, Module 3 Submissions in eCTD Format - Frankfurt, Germany
• Nov 8th, Submitting eCTD’s in Europe (MRP/DCP) “eCTD w praktyce” - Warsaw, Poland
• Nov 28th, What's New in the LORENZ drugTrack October Release? - Webinar

  

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=227 Thu, 26 Oct 2017 00:10:00 +0000
<![CDATA[LORENZ unveils three new innovations to simplify processes]]>

Frankfurt/Main, 12 October 2017 // At the keynote opening of userBridge.17, the leading annual regulatory affairs gathering hosted by LORENZ Life Sciences Group, its CEO Raoul-A. Lorenz announced three major new innovations from the world's leading supplier of e-regulatory solutions, all designed to make their target customers' workflows more efficient:

docuBridge TWO is a new version of the most widely used eCTD production and management tool LORENZ docuBridge, which is known for being used by both industry and agencies alike. docuBridge TWO is an addition to the range and is geared specifically to small- to mid-sized companies with multiple users. It fills a gap between docuBridge ONE, which is designed for producing national eCTDs on a single-user workstation at low volume, and the flagship version docuBridge FIVE which offers full features for large companies with multiple users in varied locations and a high volume of regulatory activities. Existing docuBridge FIVE customers are now being offered the option of switching to docuBridge TWO if it better fits their needs.

The 50 Publishing Token Bundle for LORENZ docuBridge ONE is an innovation that lowers the price for publishing a sequence with docuBridge ONE to just €90, representing a savings of 64%.

Adam (nickname for ‘adaptive Automator’) is a new chat-based interaction with the LORENZ Automator. Users can ask Adam, the ‘new colleague’, to do specific tasks such as starting the job of sending a submission sequence to the EMA, or showing a certain report in LORENZ drugTrack. Adam also accesses controlled vocabularies within various system environments while typing, thus simplifying any request made through natural language input.

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=226 Thu, 12 Oct 2017 00:10:00 +0000
<![CDATA[Simplification and harmonization are the keywords at userBridge.17]]>

Frankfurt/Main, 10 October 2017 // The LORENZ userBridge.17 conference, the annual ‘go-to’ event for the regulatory affairs sector focused strongly on the twin drive for simplification and harmonization. The two-and-a-half-day gathering in Nice, France, was completely sold out 8 weeks in advance, and drew 177 attendees from 22 countries. The format mixed plenary presentations from leading industry and agency figures with ample time for networking and a range of popular table tutorials; small-scale sessions focusing on specific topics.

The gathering kicked off with the unveiling of several new innovations from the host, LORENZ Life Sciences Group: docuBridge TWO, a new version of the company's best-selling eCTD solution that is tailored to small- and mid-sized companies with multiple users; Adam, a new chat-based way to interact with the LORENZ Automator; and a 50-Publishing Token Bundle for docuBridge ONE, which lowers the effective price of publishing a sequence to just €90, a savings of 64%.

The theme of simplification echoed over the three days with presentations from prominent thinkers including Hans van Bruggen of eCTDConsultancy B.V. who urged attendees to “See the unseen: across and within applications”, from Dr. Andreas Franken of BAH, the German Medicines Manufacturers' Association, who touched on the needs for standards and their communication, and from Remco Munnik of Asphalion S.L. on linking IDMP and RIM solutions.

Experiences with the complexities of global e-submissions were covered in depth by a variety of speakers including Philip D. Hall of AbbVie Ltd., Jack Daley from Gilead Sciences Ltd. and Giacomo Ridi of Menarini Ricerche S.p.A.

Agency perspectives were provided by Vianney Caron of Health Canada and Dr. med. Klaus Menges of Germany's BfArM. A separate table tutorial session gave attendees the chance to raise issues with agencies directly, and the agencies present also held a working Agency Day meeting after the conference itself.

Table Tutorials proved particularly popular. Conducted over eight parallel sessions in four different time slots, these small-group sessions included meetings with LORENZ experts on LORENZ products, tutorials on the PSUR Repository, on CESP and the near future changes to CESSP, as well as on EU IDMP SPOR and the Implementation of a Regulatory Information Management Tool.

“The continuing popularity of userBridge is gratifying to see,” said Raoul-A. Lorenz, CEO, “and we think it's because the event strikes the right balance of presentation, discussion and time for networking. We heartily thank all of our presenters and attendees for contributing to yet another remarkable event.”

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=225 Tue, 10 Oct 2017 00:10:00 +0000
<![CDATA[FDA affirms award of eCTD Contract to LORENZ]]>

Philadelphia, 03 October 2017 // LORENZ Life Sciences Group is pleased to announce that the U.S. Food and Drug Administration (FDA) has affirmed its prior award to LORENZ of a contract for “Electronic Common Technical Document (eCTD) Validation and Review Software.” To learn more about the original contract award, please see our prior announcement here.

Questions regarding the FDA-LORENZ partnership or other partnerships LORENZ has with leading health agencies around the world can be directed to Jared Lantzy, Manager of Global Regulatory Agencies and Processes, jlantzy [at] lorenz.cc.

 

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=224 Tue, 03 Oct 2017 00:10:00 +0000
<![CDATA[LORENZ userBridge.17 conference is already completely sold out!]]>

Frankfurt/Main, 26 July 2017 // LORENZ is pleased to announce that the userBridge.17 conference is completely sold out, eight weeks before the start of the event!

The 15th annual userBridge conference offers a unique opportunity for Regulatory Affairs professionals to catch up on latest developments in the sector, to exchange experiences with colleagues from around the globe in a relaxed setting, and to better understand LORENZ products.

“It is the second time we are hosting our conference in Nice, and we are thrilled to be here once again,” said Wolfgang Witzel, President, LORENZ Life Sciences Group. “The fact we ‘sold out’ so early this year indicates just how important our conference is for the e-regulatory world.”

The two-and-a-half day conference will include thought-provoking discussions about IDMP and RIM solutions, best practices around the eCTD Life Cycle Management, agency processes, and new regulatory specifications worldwide. The event will take place from 19-21 September 2017 at the Boscolo Hotel in Nice, France. LORENZ wishes all participants an interesting, successful and highly productive userBridge.17.

 

About LORENZ userBridge
Since 2003, the LORENZ userBridge conference has grown to become THE conference for learning all about current e-regulatory affairs. Speakers are recruited from the highest levels of the regulatory affairs world, and topics are selected for their timeliness and relevance to LORENZ customers.

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=223 Wed, 26 Jul 2017 00:07:00 +0000
<![CDATA[userBridge.17 in Nice, France from 19-21 September 2017: Save the date and register now!]]>

Frankfurt/Main 7 June 2017 // The Boscolo Plaza in Nice, France will be the setting for userBridge.17, the annual regulatory affairs conference hosted by LORENZ Life Sciences Group. Running from 19-21 September 2017, this forum is well-known for showcasing the very latest thinking from the world of regulatory affairs, with high-level speakers recruited to give a wide range of expert perspectives from industry, agencies and consultants.

In addition to a roster of presentations on the hottest topics in regulatory affairs, the program also foresees in-depth discussions and a range of popular Table Tutorial sessions for learning in small groups. The conference schedule also allows generous time for networking.

A variety of agency and industry players will be sharing their experiences at userBridge.17. AbbVie and Gilead will outline various aspects of e-submission processing globally. More specifically, Bayer will touch on how LORENZ drugTrack is being implemented for xEVMPD and IDMP, while Health Canada will highlight their automated processes within a regulatory agency. Several consultancy organizations will also weigh in with their expertise on technology and specification trends.

Four sessions of Table Tutorials will cover 21 different topics, including an Agency Round Table for conversation among agencies on current issues, a Meet to Talk session with LORENZ experts on docuBridge and other products, and a tutorial on the e-Submission roadmap as it relates to CESP, the EMA Gateway and the PSUR Repository.

“We continue to see just how fundamentally the digital revolution is affecting the regulatory affairs sector,” observes Wolfgang Witzel, President, LORENZ Life Sciences Group, “and given our own history as an innovator, we’re proud that userBridge has become an important meeting place for anyone wanting to keep pace with the rapid changes in the sector. We very much hope to see you in Nice in September.”

To register for LORENZ userBridge.17 on September 19th – 21st in Nice, please click here!

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=222 Wed, 07 Jun 2017 00:06:00 +0000
<![CDATA[LORENZ and Generis announce the integration of their LORENZ docuBridge and CARA products to support regulatory publishing from Documentum]]>

Sarasota, FL / Frankfurt/Main, 28 March 2017 // Generis Knowledge Management Inc. and LORENZ Life Sciences Group today announced that they started a new joint solution integrating their two products CARA and LORENZ docuBridge to support regulatory publishing from Documentum.

This strategic partnership means that Generis and LORENZ can give customers the ability to author and publish with two industry-leading solutions: CARA for authors, and docuBridge for publishers. The integration will allow a user to drag and drop contents from CARA to docuBridge submissions, leaving all technical tasks like authentication, registration and versioning to the interface between the two systems.

"There is an increasing demand from our clients to have a seamless creation-to-publishing solution, and to leverage CARA for all the additional features it brings beyond the basics of managing content" said James Kelleher, CEO at Generis. "One such area of functional integration that is critically important for the process is to streamline the publishing of content both during and at the end of creation and approval, and this is what the integration with docuBridge from LORENZ brings us."

Echoing the sentiments, Wolfgang Witzel, President of LORENZ Life Sciences Group noted that “this joint effort with Generis brings more secure functionality and additional features to the general CMS Module of docuBridge, the submission management and publishing solution from LORENZ. The two combined systems will deliver real value to customers, allowing them to be both more efficient and compliant in the challenging market of Drug Regulatory Affairs. We’re delighted with this new partnership.”

 

CARA provides customers an industry-leading, cost-effective and highly flexible user interface, either on premises or in the cloud, when they need to upgrade from Webtop; Generis’s customers include 8 of the top 10 largest Life Science companies as well as government and finance company, and there are over 300,000 licenses users of Generis software products. CARA in particular not only provides a high degree of ergonomic and functional advantages, but comes with a set of Life Sciences solutions pre-packaged as accelerators or “RapidDeploy” options, including Submission / CTD, Electronic Trial Master File (eTMF), SOPs / Quality Management, and Change Control.

LORENZ docuBridge is the most established standard solution in small, medium and large companies as well as regulatory agencies for compiling, publishing, managing and reviewing electronic submissions. The software complies with all global eCTD standards and NeeS. It also offers a clear sequence of expansions that are designed to cope with European portals, RPS, connections to third party systems and process automation.

 

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 650 paid installations in 33 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base.

About Generis Knowledge Management, Inc.
Generis has been providing leading-edge software for content management systems including Documentum, SharePoint, Alfresco and Oracle WebCenter since 1997. The company has more than 50 customers across industries from Federal Government, through Life Sciences and Engineering to Media, Publishing and Financial. The company is headquartered in Sarasota, FL, and has its principal development centers in Europe. Customers include 6 of the global top 10 Life Science companies, Federal and State governments, engineering and media companies.

CARA has recently won a number of awards including the Compliance Product of the Year, and Generis was featured in Forbes and also as one of the Top 20 Most Promising CMS Vendors by CIO Review magazine. For more information about Generis visit www.generiscorp.com

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=221 Tue, 28 Mar 2017 00:03:00 +0000
<![CDATA[State Institute for Drug Control (SÚKL) of Czech Republic will review electronic submissions using LORENZ docuBridge]]>

Praha, 10 November 2016 // The LORENZ docuBridge software solution has been selected by the SÚKL (State Institute for Drug Control) located in Praha, Czech Republic for that agency’s work in receiving, reviewing and processing electronic applications for market authorizations. The SÚKL will combine docuBridge with the LORENZ Automator service for the automated download of electronic submissions from the EMA CR.

“We’re very proud that the SÚKL have placed their trust in us for handling eCTDs and NeeS” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “Our global experience is helping more and more Health Agencies like SÚKL ensure that their review of electronically created submissions runs as efficiently and smoothly as possible. There are also significant advantages in time-saving and in the storage and handling of regulatory files. The fact that SÚKL is coupling docuBridge with the use of LORENZ Automator for its downloads from the EMA is also significant. It marks an important milestone for both LORENZ and the SÚKL.”

LORENZ docuBridge addresses all the fundamental business challenges of an eReview process, and complies with all global eCTD standards and NeeS. The software is already used by many other authorities globally, including Health Canada, the German Federal Institute for Drugs and Medical Services (BfArM), the Australian Therapeutic Goods Administration (TGA), and the Thai FDA.

 

About SÚKL
The Czech State Institute for Drug Control is an administration body established by the Act no. 79/1997 Coll. It falls under direct control of the Ministry of Health. The scope of operation of the Institute is stipulated by legal regulations. In order to safeguard its tasks, the Institute establishes regional workplaces located outside the headquarters of the Institute. The Institute's mission is, in the interest of public health protection, to ensure that all human pharmaceuticals available on the Czech market meet appropriate standards of quality, safety and efficacy to take share to ensure that only safe and functional medical devices are used in the Czech Republic, in addition, accompanied by reliable and appropriate information. Moreover, its role is to contribute to rational use and where appropriate, to responsible and ethical clinical trials of both medicinal products and medical devices.
Regulatory procedures shall not result in unnecessary obstacles to the availability of medicinal products and medical devices nor to introduction of new therapeutic procedures.

 

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=220 Thu, 10 Nov 2016 00:11:00 +0000