You may have the best idea, but mind the regulators!

Innovating in the life sciences and health care sector? If so, you can’t escape the regulators!

In a discussion entitled “Avoiding Pitfalls in the Regulatory Path,” MaRS Advisor and Life Sciences & Health Care Practice Lead, Sonia Sanhueza, shared her views on avoiding regulatory pitfalls. She highlighted the important aspects of a well-defined regulatory strategy and the things to keep in mind while implementing it. In her presentation, Sonia advised attendees on how to identify and mitigate challenges along the path to regulatory approval.

Her key messages included:

  • The importance of complying with regulatory and quality requirements
  • The significance of maintaining written procedures and documenting all the information you generate
  • How to maintain the best practice of starting with the end (result) in mind
  • The importance of developing a checklist to plan ahead and creating a clear regulatory strategy

Find below Sonia’s four hot tips, followed by her full presentation:


Here’s a video of Sonia’s discussion and presentation, part of our Best Practices series.


Here’s Sonia’s slide presentation.