Frankfurt/Main, Germany and Singapore, Singapore 30 May 2023
The consortium of LORENZ Life Sciences Group, VRG Pte. Ltd. & Websparks Pte. Ltd. has been awarded the contract to provide an eCTD reviewing solution to the Singapore Health Authority (HSA). This solution will receive and review eCTD dossiers and assist in the development of a regional schema and eCTD specification.
The consortium will provide a complete eCTD solution comprising LORENZ’s core software applications: docuBridge, eValidator, and Automator, and a portal offering from Websparks. Project management, consulting, training services, and support will also be provided by all consortium members.
HSA intends to introduce the eCTD system gradually, and its adoption for dossier submissions will be optional. The system’s initial release will cater to new drug applications, generic drug applications, and their corresponding Drug Master File (DMF) submissions.
“We are honoured to be part of the consortium which will support Singapore’s efforts to optimize its drug evaluation and approval system. We are confident that together, we can provide an integrated, world-class solution that will fully address their needs,” says Wolfgang Witzel, President of LORENZ Life Sciences Group.
Websparks is committed to working closely with HSA to ensure a successful implementation of the eCTD system. This partnership with LORENZ Life Sciences Group and VRG marks a significant milestone in Websparks’ commitment to providing integrated, world-class solutions that address the client’s needs.
Websparks is an award-winning, full-service digital web solutions company that offers web development, CMS implementation, application development, UX/UI design, and digital marketing services. Websparks has been developing and managing web development projects for many government agencies since 2008. Websparks has proven expertise in providing quality solutions in application development and integration. Websparks is an AWS APN Select Consulting Partner, a Progress Sitefinity Premium Partner, and a Sitecore Solution Partner.
With more than 130 team members, Websparks has been awarded multiple term contracts in the government, healthcare, and education sectors. To date, Websparks has served over 165 clients and managed more than 550 projects in the last 14 years. Websparks is the developer of choice for many government agencies’ web development projects.
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 toward industry, health authorities, and academia to support compliance globally. LORENZ’s tried and tested solutions cover product registration/IDMP, submission assembly, validation, management, publishing/eCTD, regulatory planning, and tracking products, as well as related services. Interoperability between LORENZ products and third-party solutions and the ability to automate processes allow its customers to enhance their operational efficiencies. With over 1700 paid installations in 48 countries, LORENZ has a strong worldwide customer base. The company headquarters is in Frankfurt, Germany.
To date, LORENZ has established eCTD systems for 13 national health authorities, including the USFDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), HPRA (Ireland), Thai FDA (Thailand) and CDE/NMPA (China).
VRG is a Singapore-based IT consultancy providing services and technology-driven solutions for Life Sciences and Engineering companies in the Asia Pacific (APAC) region.
Founded in 2018, their primary objective is to assist these companies in adopting and integrating advanced technologies through client-oriented services while considering the associated costs. VRG employs an alliance consulting model, bringing together highly experienced and respected experts with extensive knowledge in science, engineering, technology, and business. This approach allows them to offer comprehensive support tailored to each client’s needs.
VRG’s main services encompass Content Management, Regulatory Operations and Submission Management, Regulatory Affairs, Regulatory Project Management, and e-Regulatory solutions (systems integration, including cloud technology).