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Insight & Intelligence : Jul 22, 2009
Opinion—Regulatory Planning Key for Emerging Technology Companies
Strategies formed early help keep investors and partners happy as well as create a smoother development path.
Early-stage emerging technology companies are very fragile. They have very specific product development needs based not only on their technology and their financial status but the culture inherent to such companies. They need close guidance not just with a few regulatory items but with the entire path to the IND application. Very often they have no understanding of or experience working with the FDA and are usually undercapitalized. They need to multitask and balance the generation of new ideas with staying focused on the company direction.
Gary Pekoe, Ph.D., is president and CEO and Amanda Houck Miller is regulatory affairs manager, Arkios BioDevelopment International.
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