Before diving into a specific regulatory strategy, there are often corporate strategy questions to consider, such as: 

• What are the competitive prospects of my company’s regulatory pathway or product?

• Should my company focus on the largest markets first? Are there niche areas that require less time, cost less, and increase the odds of a clear, quick ‘win’? 

• Should I take my company’s device through the quickest route to clearance or approval? Is there a combination drug-device product strategy that could give my company a drug pricing premium? 

• What target indication should my company pursue first, based on scientific, medical, regulatory and commercial considerations?

Kinexum’s experts help you think through these strategic questions, which can be the most consequential decisions you make for fundraising, partnership, and commercialization.