LORENZ docuBridge®

ClinDatrix supports its regulatory affairs clients with the LORENZ docuBridge® eSubmission software package. This powerful software solution manages electronic regulatory submissions in electronic common technical document (eCTD) format.

Features

  • Compiles, publishes, manages and reviews electronic submissions to regulatory agencies worldwide
  • Provides highly efficient organization of documents into the eCTD format with seamless integration of intra-document hyperlinking
  • Complies with all global eCTD standards; regular software updates keep standards current with regulatory agency changes
  • Performs hundreds of electronic tests using the built in eValidator function on each submission to ensure technical properties of each submission meet regulatory agency standards
  • Facilitates eCTD submission, which has significant financial benefits to sponsors:
  • Reduces printing and shipping costs vs. paper
  • Enables submission to multiple countries with relatively minor changes
  • Reduces submission review and QA/QC times
  • Adds value to partnering opportunities for small companies
  • Adds more cost effectiveness than paper submission
  • Improves the review process
  • Complies with the preferred format for FDA reviewers due to the efficiency of review
  • Can be uploaded to the FDA to be available to reviewers within hours
  • Allows convenient submission navigation via hyperlinks and bookmarks
  • Used by regulatory agencies worldwide
  • Australian Therapeutic Goods Administration (TGA)
  • Thailand's Food and Drug Administration (FDA)
  • Irish Medicines Board (IMB)
  • Montenegro Agency for Medicines and Medical Devices (CALIMS)
  • Austrian Agency for Health and Food Safety (AGES)
  • Republic of Slovenia Agency for Medicinal Products and Medical Devices (JAZMP)
  • Health Canada Therapeutic Products Directorate (TPD)and Biologic and Genetic Therapies Directorate (BGTD)
  • Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • LORENZ docuBridge® is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike. With over 300 installations in over 25 countries, LORENZ has a strong worldwide customer base.