What groundwork or think tank do I need in advance so that my innovation gets a successful regulatory approval and makes it to market commercialization?

Include a regulatory strategy also in your overall strategy to take your innovation to market. Having an advisor, regulatory strategy in your think tank from day one helps not only with regulatory but also to answer questions and pitch to VC's. 

The subject matter expert (SME) should be part of your think tank from the start and not at the end, like marketing. The  SME advises you from the cradle to the grave of all local and global regulatory hurdles and obstacles you may face at the beginning of the journey, thus avoiding expensive surprises. The SME shares with you all the issues and concerns of pre-market and post-market surveillance. The SME also provides information related to R&D and testings that should be completed in the product development stage for various robust markets like China and Russia in advance.

SME prevents you from making any crucial mistakes that can be very expensive for a startup. The SME helps your innovation get to market with no roadblocks or delays and in a cost-effective manner.

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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