Regulatory Support

Submissions

From handling meetings with regulatory agencies to guiding your organization on current requirements we can help your organization with the best approach to submissions. Our regulatory experts have dozens of successfully approved products and a wide range of expertise with:

  • INDs

  • NDAs/ANDAs

  • BLAs

  • 510Ks

Strategy

In order to get submission ready our consultants can help guide on current industry best practices and give support where needed. We tailor our advice to be phase appropriate while preparing your organization with the necessary steps and timelines that will make you best prepared to become commercial ready. Areas of support may include:

  • Pre-Submission Activities

  • Global Trial Planning

  • Response Letters

  • Working with Multiple Markets

  • Acquisitions and Business Integrations

  • Drug Developmental Issues