Our regulatory operations staff are quality driven experts in electronic publishing standards for both the US and EU. We offer complete product lifecycle management from pre-IND through post-marketing in compliance with ICH guidelines and FDA specific publishing specifications. We provide rapid, client-responsive submission timelines.

We can:

  • Format and Publish Clinical Study Reports
  • Publish Expedited Safety Reports
  • Perform OCR
  • Manage datasets and images
  • Manage and Publish Major Regulatory Submissions including INDs, NDAs, and BLAs
  • Manage and Publish Post-approval Submissions including CBE0 and CBE30
  • Work with CRO platforms for publishing