eCTD Publishing and Submissions

eCTD (electronic Common Technical Document) is an electronic format that supports the submission of applications, amendments, supplements and reports to the United States Food and Drug Administration (USFDA).

eCTD facilitates the quick creation and review of electronic data with a flexibility to integrate metatags, hyperlinks and bookmarks to the data. eCTD enables efficient assessment and effective lifecycle management of submissions for quicker market approvals/authorizations.

Our highly experienced team of regulatory affairs professionals deliver complete regulatory submission services to our clients. We help guide and support you to meet regulatory requirements throughout the different stages of drug development and post approval.

MABH supports:

  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Biological License Application (BLA)
  • Over the Counter (OTC)
  • Drug Master Files (DMF Submissions)
  • Structured Product Labeling (SPL) Submissions
  • supplemental new drug application (sNDA Submissions)
  • Originals, Amendments, Annual report Submissions
  • Labeling Supplement Submissions
  • Periodic Adverse Drug Experience Report (PADERS)

  • Why MABH eCTD Publishing?

  • Periodic training and updates on the ever-changing global Regulatory requirements.
  • Continuous project monitoring
  • Periodic quality check for effective time management.
  • Detailed tracker creation to track all the version changes made through publishing lifecycle.
  • A team of qualified publishing and submission experts.
  • A robust eCTD publishing and submission software.
  • eCTD Submission roadmap right from compiling original submissions to maintaining lifecycle.
  • Error-free submissions that enable your organization to focus on core business functions.