Egnyte and Lorenz Life Sciences Announce Integration Supporting Regulatory Document Management
New integration permits documents created and stored within Egnyte to be included in an eCTD formatted regulatory filing
Mountain View, CA. – May 7, 2024
LORENZ Life Sciences and Egnyte today announced an integration in the upcoming LORENZ docuBridge 24.1 release, enabling customers to easily use documents created and managed within Egnyte for regulatory submissions. With the new connector, LORENZ is closing the loop and allowing seamless integration between Egnyte workflow processes and LORENZ workflow processes.
“Halloran is happy to partner with LORENZ and Egnyte to deliver an effective solution,” said Sheila Gwizdak, vice president, head of consulting at Halloran Consulting Group. “This is an example of a technology integration improving efficiency, maintaining control of critical submission documents, and enabling Halloran to provide high quality regulatory services to the life science companies we serve.”
This integration provides a seamless system for Egnyte customers to compile content such as preclinical toxicology data, clinical protocols, statistical analyses, and case reports in docuBridge preserving all metadata and without losing data integrity. This eCTD publishing connection is a required step when submitting an Investigational New Drug (IND), New Drug Application (NDA), or Biologics License Application (BLA) to a regulatory agency such as the
Food and Drug Administration. Throughout the process, the companies worked to ensure the support of Inter-Document Hyperlinks to simplify the submission validation and reviewing process.
“Customers will benefit from Egnyte's robust and secure content management features while leveraging the proven lifecycle management capabilities for submission documents from docuBridge,” said Abhay Kini, director of Life Sciences at Egnyte. “We are excited to launch this critical integration for Egnyte’s Life Sciences customers and we are grateful to the LORENZ team and Halloran Consulting Group for their collaboration on this effort.”
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market for over 30 years. The LORENZ Regulatory Information Management solutions address industry, health authorities and academia to ensure compliance enforcement worldwide. LORENZ’s proven 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. LORENZ has a strong customer base worldwide, with over 1800 paid installations in 48 countries, including 15 agencies.