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
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