SUBMISSION MANAGEMENT

Regulatory submission management is a complex process that is part art and part science. The WAYS team makes it look easy.  We partner closely with our client teams. We take care of the entire process or fill specific resource gaps so our clients can focus on innovative science. 

Organization

  • Timeline management

  • Develop and manage content plan

  • Clearly define responsibilities / communication plan

Compilation

  • Manage issues from identification through resolution

  • Track and manage version control challenges

  • Leverage technology where appropriate

  • Employ best practices to produce process efficiency

Publishing 

  • Manage content plan against agency requirements

  • Analyze and publish submission components and interpret guidance requirements for each

  • Apply practical knowledge of validation criteria

  • Use enabling technologies to verify compliance and view the final output

  • Manage process that is informed by practical experience and driven by best practices

Dispatch

  • Obtain signing certificate for the FDA Electronic
    Submissions Gateway (ESG)

  • Submit premarket and postmarket regulatory information for FDA review

  • Manage gateway receipts for clients

Maintenance

  • Understand and communicate agency deadlines

  • Respond quickly and efficiently to present challenges, opportunities, and options