Dr. Isabella Steffensen

Dr. Isabella Steffensen

Dr. Isabella Steffensen is a biomedical scientist and President of Thera-Business Consulting. Over the past 20 years, Dr. Steffensen has assisted pharmaceutical and medical device companies with technical, regulatory, marketing, and business development issues. She has extensive experience preparing clinical evaluation reports and other regulatory documents, as well as other evidence based-reports such as practice guidelines and systematic reviews.
What is Regulatory-Grade AI?

What is Regulatory-Grade AI?

We keep getting asked the same question: if we use general-purpose AI tools to support a regulatory submission, will the output stand up to a regulator, a payer, or a notified body? Every day, medical affairs, HEOR, and regulatory teams conduct literature reviews that...