Getting your medicinal compound authorized can be a challenge. The European Medicines Agency and National Competent Authorities offer scientific services that help you maximize the chances of getting your product approved, but preparing your submission and meeting the authorities requires thorough preparation.
Bronsing Life Science Consultancy:
- helps writing your briefing book
- applies for Scientific Advice (SA) or Protocol Assistance on your behalf
- arranges and attends meetings – or coaches your meeting delegates
- guides you through the SA process
- helps you interpret the results
Is Scientific Advice legally binding?
No, an Advice is not legally binding, but it will give you an impression of what the authority thinks of your program and what to look out for when writing your protocol. It also allows you to ask specific questions to the authorities.
What is the best time to apply for Scientific Advice or Protocol Assistance?
While you can apply throughout the development process, it is recommended to apply early on, e.g., between the pre-clinical phase and exploratory clinical testing – especially if your application concerns a new medicinal product.
Would you like to know more?
Download the brochure or contact Bronsing Life Science Consultancy.