Regulatory Submission Writing Training

regulatory submission writing training, regulatory submissionsLike all Working Words training programs, this one stands firm on a foundation of improved critical thinking, as well as clearer writing.

Writing regulatory submissions (INDs, NDAs, and BLAs) is a matter of making a persuasive case, which depends upon good analysis and well-reasoned conclusions supported by evidence. It is a matter of interpreting and using data to make a well-reasoned argument that demonstrates:

  • the quality, safety, and efficacy of the product
  • the control strategy to ensure this quality

The course is designed to ensure that participants understand the consequences of unclear writing that is ambiguous and fails to present a clear, persuasive case in regulatory submissions, e.g.:

  • Questions during review.
  • Delay in approval and product launch.
  • Pre-Approval Inspection (PAI) queries
  • Post-approval commitments (e.g., additional stability batches, additional validation, etc.)
  • Complete Response letter rather than first-time approval.
  • Poor reflection on company's reputation for submission writing, which may cause higher scrutiny for future submissions.

Working Words consultants will also analyze forms and templates and the system in which regulatory documents are created to ensure that it is designed for maximum efficiency and effectiveness. This work contributes significantly to the long-term success of all training efforts.