Ms_OsadaMs. Osada

Bi-lingual (Japanese and English)

eCTD Publishing and Submission Specialist

As a team leader in the digital marketing function and regulatory operation with a focus on eCTD formatting, publishing, and submission, Ms. Osada organizes and develops plans to support company’s digital media and maintenance eCTD template, format, software, and FDA related regulations up to date.

Ms. Osada studied at The University of London with a major in Bachelor of Science in Marketing and also received training for eCTD structure, formatting, publishing, and submission.

Regulatory Project Management Support and eCTD publishing and submission Expertise:

  • Original IND
  • Original NDA/BLA
  • DSUR
  • Regulatory Intelligence
  • Submission Planning
  • Document Management
  • Formatting and Publishing
  • E-Submission
  • Submission Tracking