The development of new drugs is essential to patients and healthcare systems but requires significant investment and risk taking. At the same time, both costs and time of drug development have increased over the past decades resulting in higher pressure on development programs. To avoid pitfalls, it is critical to define an effective regulatory strategy early on and to integrate it in the development program.
In her most recent article, Dr. Diane Seimetz, Founding Partner of Biopharma Excellence, provides expert guidance on:
- How to set up an effective regulatory strategy.
- Which regulatory tools are available for an effective regulatory strategy.
- How an approval process works.
- The value of partnering.
- What the most important do’s and don’t’s are.