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.