Ensure the Success of your Submissions with Synchrogenix

For successful electronic submissions, dedicated publishing teams, scalability, and visibility throughout the entire process make all the difference between a stressful submission and a streamlined submission. Synchrogenix's experienced publishing teams backed by our subject matter experts provide the dedicated attention your submissions deserve to achieve submission success.  

Regulatory Operations Services: 

  • Investigational and Marketing application submissions
    • Investigational New Drug (IND) submissions
    • New Drug Application (NDA) submissions
    • Abbreviated New Drug Application (ANDA) submissions
    • Biologics License Application (BLA) submissions
    • Drug Master File (DMF) submissions
    • Marketing Authorization Application (MAA) submissions
    • Non-eCTD electronic Submissions (NeeS)
  • Lifecycle maintenance submissions
  • Structured Product Labeling
  • Paper to electronic common technical document (eCTD) conversions
  • eCTD Submissions Management Software Suite for those looking to bring Regulatory Operations Services in-house

Synchrogenix provides solutions to address the industry’s greatest challenges

  • Global publishing teams to take advantage of regional expertise and around the clock operations
  • Secure, validated CLOUD-based software suite
  • Dedicated publishing team across your entire submission lifecycle
  • Scalability to meet changing requirements and timelines
  • Best practices training for authors
  • Expert advice on regulatory standards and best practices for electronic submissions
  • Support for all regions accepting electronic submissions