Strategic Regulatory Affairs

Complex oncology demands a team of experienced professionals who are in tune with the unique development and regulatory challenges. OncoBay Clinical’s way of approaching trial design ensures that you get the most aggressive path to regulatory approval while ensuring that all requirements are met along the way.
Strategic Regulatory Affairs

Capabilities include:

  • Consultation on strategic planning (Target Product Profile)
  • Consultation on design of your pre-clinical strategy
  • Evaluation of dossier against industry standards and regulatory requirements to pinpoint what may be missing for a successful submission (GAP analysis)
  • Consultation on the content, writing, and support for pre-IND submissions assuring that the client receives the constructive Agency feedback needed
  • Provide publishing support for regulatory submissions
  • FDA relationship management
  • Medical Writing – Essential regulatory, Medical, development, and pre-clinical

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