What's the best regulatory pathway I should take for a successful regulatory approval and market access?

The regulatory pathway depends on the technology of your innovation. Sometimes because of the technology of your innovation, you can get faster market approval via the FDA (US) than the EU. Sometimes it can be the opposite where the technology of your innovation can get speedier approval via the EU than the USA. It's best to utilize the MIT advisor, regulatory strategy who is the subject matter expert (SME), and help you by figuring this out for you and help you take your innovation to market on time and in a cost-effective manner. 

The SME knows the local and global regulations very well and will also provide all crucial information like lucrative global markets and testing, etc. to be completed in advance before hitting that particular market. 

Your advisor, regulatory strategies is your mini-CFO. 

Trilo Das, Regulatory affairs, pharma and medical devices expert

Professional Advisor at the Martin Trust Center for MIT Entrepreneurship


Was this article helpful?
0 out of 0 found this helpful



Please sign in to leave a comment.

This website and all posts and content are intended for educational purposes only and for no other purposes including without limitation commercial purposes. Any other use must give proper attribution to the Martin Trust Center and is subject to certain legal rights contained in our license and terms of use. See full legal disclaimer HERE .
The content in this knowledgebase is subject to a non-exclusive license with share-alike restrictions and the terms of use of this site – which is available for your review HERE .

Have more questions?
Submit a request
Share it, if you like it.