60 LORENZ Life Sciences News Feed List of all press releases issued by LORENZ. http://www.lorenz.cc <![CDATA[Alliance of Experts: Your partner for an end-to-end RIM solution in Life Sciences]]>

Frankfurt/Main, Germany and Amersham, England and Sarasota, FL, 12 February 2019 // Generis, Phlexglobal and LORENZ Life Sciences Group, announce the founding of the Alliance of Experts, a new source for end-to-end Regulatory Information Management (RIM) and Clinical solutions in Life Sciences. The Alliance of Experts brings the expertise of each company together to provide seamless interoperability between their software packages, providing customers a ‘single source of truth’ for all data that can be used and applied in multiple solutions.

Prior to the founding of the Alliance of Experts, life science customers either employed a range of specialized tools from several different domain specialists to meet RIM requirements which may not work together or purchased a single solution RIM enterprise tool that provided limited depth of expertise in the rapidly changing life science market. The Alliance of Experts offers the best of both worlds by providing expert, established applications and guaranteeing the integrations between them with a single Alliance support service. This approach removes the burden of maintenance and risk from our customers, while ensuring zero compromise on functionality.

A prime example of an effective RIM solution provided by the Alliance of Experts is the Submission Archiving function. Leveraging the integration between LORENZ docuBridge and  Generis’ CARA, Submission Archiving pushes an archive copy of the published submission into CARA for long term storage, while creating an application sequence in docuBridge that includes leaf nodes pointing to the relevant files in CARA. Archived submissions can be accessed from CARA or from docuBridge with equal ease, giving customers exactly the same view of the submission that the agency has, along with links to the source files of their published equivalents.

“The whole point of the Alliance of Experts is efficiency,” says James Kelleher, CEO at Generis, “and this means that customers benefit directly from having a single source of regulatory data that can feed many different processes. This means that the sheer number of sources of error are greatly reduced.”  

Karen Roy, Chief Strategy Officer from Phlexglobal echoes the sentiment: “Combining our Clinical expertise with the Alliance’s Regulatory Affairs expertise really creates a whole new user experience. Customers can assemble their own perfect solution from a range of different partial ones.”

"The Alliance of Experts combines the advantages of a single RIM vendor and at the same time overcomes the limitations of a single RIM vendor," says Raoul Lorenz, CEO of LORENZ Life Sciences Group, "Through 'automated integration' we are taking the headache out of system integration, and are able to offer more variety and much deeper functionality. This is a marked step forward from both the classic approaches as well as the rigid platforms that have tried to replace them."

For more information of how the Alliance of Experts has created agile, tailored, end-to-end solutions to help customers, check out the joint initiative’s website.

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 that enable compliance enforcement globally. LORENZ' 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 1050 paid installations in 38 countries, LORENZ has a strong worldwide customer base.

About Generis Knowledge Management

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 8 of the global top 10 Life Science companies, Federal and State governments, engineering and media companies.  For more information about Generis visit  www.generiscorp.com.

About Phlexglobal

Phlexglobal are world renowned thought leaders and specialists in the provision of electronic Trial Master File (eTMF) systems and services. They offer a unique combination of eTMF technology with PhlexEview – their market leading eTMF system, quality services and specialist resource that delivers a range of flexible, targeted solutions to meet your business needs. Phlexglobal is headquartered in the UK, with offices in Malvern, PA and Lublin, Poland. 

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=238 Wed, 13 Feb 2019 00:02:00 +0000
<![CDATA[Register now for LORENZ' RIM Solutions Conference to be held in New Orleans, April 9-10, 2019]]>

Frankfurt/Main, 11 January 2019 // LORENZ’ annual Regulatory Information Management Solutions conference (LORENZlink) will take place at the Astor Crowne Plaza Hotel in the French Quarter of New Orleans, where Canal Street meets Bourbon Street. This annual conference attracts LORENZ customers, partners and other RIM professionals for two days of presentations, networking and exchange of ideas.

Established under the overall theme “Converge, Connect and Collaborate,” the conference covers a wide variety of presentations and tutorials focusing on practical solutions for current challenges regulatory and IT professionals face. Topics will include:

  • Synchronization of metadata attributes with master data in support of searches
  • Data import challenges and solutions
  • Managing Combination Products
  • Working with the eCTD format in global products
  • Updates on electronic submissions at Health Canada
  • Practical applications of artificial intelligence in regulatory writing and publishing 

Participants will also have an opportunity to explore in depth the full range of LORENZ products during the following discussions: What’s New in LORENZ docuBridge, Understanding LORENZ as a view Tool, Practical Solutions for LORENZ Automator and LORENZ drugTrack – Benefits and Business Cases.

LORENZlink also includes a range of table tutorials geared towards smaller groups of less than 25 people. These interactive group sessions will give participants the chance to dive into selected topics in depth, and discuss challenges that are relevant to them.

An optional product training day will follow on April 11, offering a choice between an advanced docuBridge FIVE training or a basic docuBridge ONE training. Both sessions will cover creating a new application (US version 3.3) and the basics of compiling modules 1 (regional information), 2, 3, 4 and 5 (STFs), as well as how the US FDA reviews applications.

“We are once again looking forward to welcoming a distinguished faculty of LORENZ customers, partners and staff as we learn from each other and plan for the future” said Yaprak Eisinger, Managing Director, North America, LORENZ Life Sciences Group. “We hope New Orleans will provide an unique backdrop with its distinctive blend of people, food, music and traditions.”

Click here to register now and save your space! 

For information on the conference and/or the additional training day, please contact:
Maria DeRose, mderose@lorenz.cc
Phone: +1 914 584 1955

 

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' 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 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. 

  

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=237 Fri, 11 Jan 2019 00:01:00 +0000
<![CDATA[ERIS and LORENZ announce exclusive partnership agreement for China]]>

(Click here for Chinese version)

Frankfurt/Main and Beijing, 05 November 2018 // Beijing ERIS Information Technology Co, Ltd. ("ERIS") and the German LORENZ Life Sciences Group ("LORENZ") recently signed a cooperation agreement, officially designating ERIS as the exclusive agent and distributor for LORENZ e-regulatory affairs solutions in mainland China.

 

 

Under this new cooperation framework, ERIS will be responsible for the marketing, distribution, implementation and local maintenance of LORENZ docuBridge and eValidator. Small, medium and large companies as well as regulatory agencies use docuBridge to compile, publish, manage and review electronic submissions. The software generates submissions that comply with Chinese and global eCTD standards. NeeS, VNeeS, HTML, PDF, and paper formats are also supported. eValidator technically validates eCTD, NeeS, PDF and other submissions to verify and ensure compliance with the standards of health agencies in China and other countries. ERIS will be dedicated to provide the world's most desirable e-regulatory affairs solutions to domestic pharmaceutical companies, contract research and consulting companies, assisting clients in meeting China’s eCTD regulatory requirements, and improving the quality of eCTD applications. This process will help accelerate the approval and launch of their products.

ERIS is pleased to note that on July 02, 2018, Shanghai Baosight Software Co., Ltd. ("Baosight Software") was selected to establish an eCTD data management system for Chinese Center for Drug Evaluation, NMPA. LORENZ had entered into an agreement with Baosight Software to provide LORENZ’ docuBridge and eValidator as an eCTD review system, validation system and document management system required by CDE, as well as corresponding consulting and training services. ERIS will now assist LORENZ and Baosight Software in implementing the eCTD data management system for the CDE.

 

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ offers a wide array of Regulatory Information Management solutions geared towards industry, health authorities and academia in order to support compliance globally. LORENZ' tried and tested solutions cover product registration/IDMP, submission assembly, validation and management, publishing/eCTD, regulatory planning and tracking products, as well as related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes, allow its customers to enhance their operational efficiencies. With over 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. The company headquarters is located in Frankfurt, Germany.

To date, LORENZ has established eCTD systems for 12 national health authorities, including the USFDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), and the Thai FDA (Thailand). It is currently assisting CDE, NMPA (China) in establishing its eCTD data management system.

About ERIS
ERIS (www.eris-bj.com) focuses on electronic regulatory services. Based on the experience of providing registration regulatory and information services, ERIS is dedicated to providing the clients with the world's most desirable e-regulatory affairs solutions, as well as local installation, configuration, training, regulatory consultation, and post maintenance services, fully meeting clients’ needs in eCTD application management.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=236 Mon, 05 Nov 2018 00:11:00 +0000
<![CDATA[LORENZ docuBridge and eValidator selected by the Chinese NMPA for an eCTD Data Management System]]>

(Click here for Chinese version)

Frankfurt/Main and Beijing, 02 November 2018 // On July 02, 2018, the Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) selected Shanghai Baosight Software Co., Ltd. in a tender to establish the eCTD data management system, and LORENZ was chosen by Baosight as software provider in this project.

To establish the eCTD data management system, LORENZ will provide docuBridge and eValidator as an eCTD review system, validation system, and document management system required by CDE, as well as corresponding consulting and training services.

The project is a milestone for all parties. Baosight Software and LORENZ are strongly committed to the CDE’s ambitious goal of implementing eCTD submissions as early as 2019.

Since joining the ranks of the ICH – the international body that sets the standards for harmonizing pharmaceutical registrations globally - in June 2017, China has been eager to adopt its standards. This move will widen access to China’s pharmaceuticals market for foreign companies while also enabling local producers to export regulated products much more easily. China’s ICH membership is what has triggered the speedy move to the eCTD format.

“LORENZ is truly proud to be supporting the acceleration of Chinese drug evaluation and approval system, and we aim to provide an integrated, world-class solution that suits the NMPA perfectly” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “Together with Baosight Software, we’ll be using our global experience to ensure that the implementation of the eCTD format in China runs as smoothly as possible.”

 

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ offers a wide array of Regulatory Information Management solutions geared towards industry, health authorities and academia in order to support compliance globally. LORENZ' tried and tested solutions cover product registration/IDMP, submission assembly, validation and management, publishing/eCTD, regulatory planning and tracking products, as well as related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes, allow its customers to enhance their operational efficiencies. With over 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. The company headquarters is located in Frankfurt, Germany.

To date, LORENZ has established eCTD systems for 12 national health authorities, including the USFDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), and the Thai FDA (Thailand). It is currently assisting CDE, NMPA (China) in establishing its eCTD data management system.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=235 Fri, 02 Nov 2018 00:11:00 +0000
<![CDATA[userBridge.18 highlights need of semantical interoperability]]>

Frankfurt/Main, 01 October 2018 // LORENZ userBridge.18 in Prague was completely sold out once again this year, drawing more than 180 attendees from industry, consulting and regulatory health agencies around the globe. Hosted at the centrally-located Hotel Ambassador Zlata Husa from 18-20 September, the conference was packed with presentations, table tutorials and panel discussions covering current issues in the Regulatory Affairs sector, all in line with the userBridge motto:  “Learn – Discuss – Interact”.

The event kicked off with a LORENZ keynote presentation showcasing the company’s move to a shared business logic of its solutions using semantical interoperability within the LORENZ Foundation. Christian Kaas, Managing Director Research & Development at LORENZ, also gave live demonstrations of the company’s Regulatory Information Management (RIM) approach and Adam, its virtual regulatory NLP Assistant. The RIM topic was also echoed in many other userBridge presentations including “RIM – a single system or a happy family” and “RIM implementation and integration. Tailoring the evaluation for the right solution”. 

The wide range of userBridge presentations captured the spirit of the times. Prof. Sir Alasdair Breckenridge considered the possible implications of the Brexit on the Regulatory Affairs world. Presentations about IDMP and SPOR also gave participants a better understanding of these emerging trends in the sector.  

 

 

Many prominent Regulatory Affairs consultants and industry experts shared their insights with participants, including Remco Munnic of Asphalion, Elke Schydlo of Sandoz, and Dr. Andreas Franken of the German Medicines Manufacturers’ Association (BAH) among many others. Agencies were also well represented, including an update from Health Canada by Vianney Caron and a presentation from Dr. Klaus Menges of the German authority BfArM.
 
A selection of 24 different table tutorials – small-scale learning and Q&A sessions on specific topics – gave attendees the chance to pick and choose several sessions. The bandwidth of tutorials ranged from LORENZ product news such as “LORENZ Automator: Do you know Adam?” and “What´s new in LORENZ docuBridge?” to more broad Regulatory Affairs topics such as eCTD 4.0 and getting submissions ready.
 
In the breaks between the presentations and tutorials, participants had plenty of time to network with LORENZ representatives and other colleagues in the Regulatory Affairs arena. During the evening events, after the presentations, they also had time to talk in a more open way. This way, LORENZ offered an environment perfectly made to learn, discuss and interact with colleagues outside of the daily routine. 
 
“We always feel honoured that so many Regulatory Affairs experts with such diverse backgrounds all make a point of attending userBridge, year after year,” noted Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, “and we’re very happy to provide this kind of forum for leading edge thinking in the sector.”  
 

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' 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 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=233 Mon, 01 Oct 2018 00:10:00 +0000
<![CDATA[Otsuka selects LORENZ docuBridge to manage eSubmissions worldwide]]>

Tokyo and Frankfurt/Main, 01 October 2018 // The Otsuka Pharmaceutical Co., Ltd., a Japan-based holistic healthcare company, has chosen LORENZ’s docuBridge as their global eSubmission management system. The docuBridge solution will be adapted to support Otsuka’s operations in Japan, the EU, the USA, Canada, as well as its affiliates Taiho Pharmaceutical, Taiho Oncology, Astex Pharmaceuticals, and Avanir Pharmaceuticals.

"We are very pleased to award Otsuka’s next generation global publishing platform to LORENZ. The detailed product evaluation by our global team unanimously recommended docuBridge as solution of our choice for its usability, sequence management that supports global submissions, and expanding use by regulatory authorities as their viewer and validation solution.” says Kenji Nagamura, a senior member and sponsor of the product evaluation team at Otsuka.  

“LORENZ would like to congratulate Otsuka for selecting the most advanced solution available in today’s marketplace. We’re gratified by their decision, and are collaborating closely to ensure a successful global implementation,” says Wolfgang Witzel, President of LORENZ Life Sciences Group. “Our docuBridge solution will ensure that Otsuka can efficiently meet the constantly evolving Regulatory requirements across all markets.”

“We are very happy to partner with LORENZ to support Otsuka in adapting docuBridge to the specific needs of Otsuka in Japanese region,” says Hiroji Emoto, President and CEO of Digital Media System Co., Ltd., the exclusive distributor for docuBridge in Japan. “This solution will greatly increase the productivity in managing the eSubmissions around the globe – and contributing to Otsuka’s mission of improving and supporting the health of people.”

LORENZ docuBridge is the most advanced multi-user eSubmission production and management system for small, medium and large companies as well as regulatory agencies to compile, publish, manage and review electronic submissions. docuBridge complies with all global eCTD standards, NeeS, VNeeS, paper submissions and more. The solution was also recently selected by the USFDA as part of its RIM portfolio. 


About Otsuka
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical at www.otsuka.co.jp/en/

About DMS (Digital Media System Co., Ltd.)
DMS has been a LORENZ partner since 2004 and has actively been involved in developing the Japanese eCTD market for the LORENZ docuBridge Submission Management System software. DMS has been instrumental in aiding in the development of the Japanese language module and continues to provide local support, training, installation and validation to LORENZ’ Japanese customers. DMS has been providing a Japanese eCTD Compilation Service using LORENZ docuBridge since 2006. In close collaboration with local partners, DMS has been further developing and tailoring the product for Japanese pharmaceutical manufacturing and marketing approvals. DMS pioneered the Japanese regulatory affairs market by laying the groundwork for the first ever original eCTD submitted to the Japanese PMDA by Chugai Pharmaceutical Co., Ltd. in 2005.

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 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=234 Mon, 01 Oct 2018 00:10:00 +0000
<![CDATA[userBridge 2018 in Prague - The countdown has started!]]>

Frankfurt/Main, 17 May 2018 // The countdown to the LORENZ userBridge 2018 conference has begun! In just 18 weeks, industry and authority professionals from around the globe will gather in Prague to discuss current challenges and solutions in the world of e-regulatory affairs. This two-and-a-half day event hosted by LORENZ Life Sciences Group runs from the 18th to the 20th of September 2018, and will include a range of expert presentations designed to give participants useful new insights into current issues.

In addition to the speaker presentations, userBridge will once again offer a wide selection of table tutorials; small group discussions that each focus on a single issue. These sessions offer the chance to ask questions, get answers and understand how others have solved similar issues. Participants can sign up for table tutorials, selecting whichever topics are most fitting.

All presentations and table tutorials relate to key issues in regulatory affairs, and will cover most of them from both industry and agency perspectives:
         • Regulatory specifications
         • Regulatory strategy
         • Industry processes
         • Agency processes
         • IT in regulatory affairs

The entire conference is built around the motto ‘’learn, discuss and interact’’; giving participants the chance to network, exchange experiences and reach a deeper understanding of complex topics. The event will take place against the backdrop of Prague, the Czech Republic’s lovely capital.

Please click here to register for LORENZ userBridge.18 conference on 18th – 20th of September in Prague!

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' 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, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=232 Thu, 17 May 2018 00:05:00 +0000
<![CDATA[Japanese customers gather for DMS User Group 2018]]>

Frankfurt/Main, 9 May 2018 // The DMS User Group, a gathering of 60 participants from 27 pharmaceutical companies that use DMS and LORENZ software solutions, was held on April 23rd at the Marunouchi Hall & Conference Square in Tokyo. The conference setting offered a grand view over Marunouchi Station Square, which opened last year ahead of the 2020 Olympic Games. The year 2020 will also mark the point when all New Drug Applications in Japan must be submitted using the eCTD format.

Version 4.0 of eCTD was the clear focus of the gathering, which covered many aspects of the topic including: CDISC handling for PMDA and FDA; the global challenges the companies will face in processing the new standard; and the ICH and PMDA Implementation Guides. There were also presentations by users recounting their own stories of how they have benefited from the eCTD format. Most notably, how the upcoming eCTD version encouraged them to switch from outsourcing submission production to handling the task in-house.

In a live demonstration, LORENZ gave users a clear idea of how eCTD v4.0 functions like Controlled Vocabularies, Document Reuse and the unique Japanese submission life cycle requirements with Response Submissions can all be handled in docuBridge.

The DMS User Group also marked the celebration of two significant customer milestones. First, the Mitsubishi Tanabe Pharma Co. celebrated its 10th anniversary of having LORENZ docuBridge on-premises. And second, the Daiichi Sankyo Co. achieved a total of 25 initial eCTD submissions compiled using LORENZ docuBridge. LORENZ extends its warm congratulations to both of these valued customers for their accomplishments.

The event was a great success and LORENZ Life Sciences Group was honored to participate. LORENZ also extends a hearty thank you to DMS for the organization of the User Group and for the warm hospitality!

 

 

About DMS (Digital Media System Co. Ltd.)
DMS has been a LORENZ partner since 2004 and has actively been involved in developing the Japanese eCTD market for the LORENZ docuBridge Submission Management System software. DMS has been instrumental in aiding in the development of the Japanese language module and continues to provide local support, training, installation and validation to LORENZ’ Japanese customers. DMS has been providing a Japanese eCTD Compilation Service using LORENZ docuBridge since 2006. In close collaboration with local partners, DMS has been further developing and tailoring the product for Japanese pharmaceutical manufacturing and marketing approvals. DMS pioneered the Japanese regulatory affairs market by laying the groundwork for the first ever original eCTD submitted to the Japanese PMDA by Chugai Pharmaceutical Co., Ltd. in 2005.

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, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=231 Wed, 09 May 2018 00:05:00 +0000
<![CDATA[LORENZlink 2018 – Second North American RIM Conference hosted by LORENZ Life Sciences Group]]>

Frankfurt/Main, 3 May 2018 // LORENZlink 2018, the 2nd North American conference by LORENZ Life Sciences Group took place during April 16-17, 2018 in Nashville, Tennessee at Gaylord Opryland Resort and Convention Center. Once again, the event was sold out. Over 110 attendees from industry and regulatory health agency sectors participated in two days of presentations, tutorials and panel discussions on regulatory topics.

During the keynote presentation LORENZ highlighted the need of interoperability and simplification in the eRegulatory Affairs world. These topics were often picked up by other speakers as well. For example, Sandra Krogulski from Accenture Accelerated R&D Services gave insights on RIM Technology and understanding the development of related processes while Maria Crump, Regulatory Professionals, Inc., talked about key success factors in approaching eTMF from start to finish. Teresa Martins from Bayer shared her experiences of an AdPromo Launch submitted in eCTD format and Health Canada’s Irena Pastorekova gave a valuable update on Electronic Submissions at Health Canada.

A panel discussion led by Antoinette Azevedo from eSubmissionsSolutions.com broached the challenges of Content Management and Submission Publishing in the Cloud. Representatives from Veeva, Court Square Group, United Therapeutics Corporation and LORENZ joined the discussion.

Already an inherent and favored part of LORENZ events, also in Nashville, table tutorials gave participants the chance to cover specific topics in smaller groups with face-to-face discussions and demonstrations on topics as varied as “Implementing RIM in Your Company”, “Regulatory Updates” and “New Hyperlinking Functionality in LORENZ docuBridge”.

During the optional docuBridge training day following the conference itself, participants learned how to create a new application as well as the basics of compiling modules 1-5. Elsmari Eggers from LORENZ also taught them many tips and tricks for working with LORENZ docuBridge.

“LORENZlink’s philosophy is to Converge, Connect and Collaborate, and this is exactly what the last days were all about.” said Yaprak Eisinger, MD North America, after the event. “We were happy to once again be the host of this platform of thoughts exchange and I am especially happy to see that our customers and partners also enjoyed the beautiful city of Nashville.”

The next LORENZlink conference will take place in April 2019 in New Orleans, Louisiana. The exact date will be announced in the near future on LORENZ’ website, www.lorenz.cc.

  

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' 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, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=230 Thu, 03 May 2018 00:05:00 +0000
<![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/about/press-releases/press-release.cfm?ID=229 Wed, 29 Nov 2017 00:11:00 +0000