Depending on which stakeholder you want to approach, a regulatory roadmap comes in different shapes and sizes. Within the roadmap, you will find a list of recommendations. These recommendations can for example include:
- Regulatory strategy and legal basis for registering the proposed indications.
- Potential expedited pathways and their likelihood of success.
- A communication plan for scientific advice meetings and other kinds of interactions with authorities.
- Plan for pediatric studies.
- Chances as well as pros and cons of getting a conditional (EU) or accelerated (US) approval.
- Possibilities for data exclusivity and patent extensions.
Pro-tip: Be prepared to change course
It's inevitable that contingencies will happen. Even so, when new information comes to your desk, you should be prepared to change the roadmap as it should be viewed as a living document that requires ongoing work. You see, being prepared to reevaluate your regulatory strategy strengthens the odds of you succeeding with your project.
How to begin? A first meeting is a good start 👇
