The biotechnology industry is a rapidly growing, highly competitive field worldwide.  To bring a new technology to market requires adequate funding and a knowledge of the many regulatory requirements related to your technology’s classification. Countries around the world have similar but also varying requirements.

We can help you answer questions such as:


  • Is your technology subject to “General Controls” or Special Controls”?
  • Do you need a Premarket Approval?
  • Can you claim clearance via a 510(k) application showing “Substantial Equivalence” to an already approved technology?
  • Does  your technology qualify for a De Novo classification?

Some of our services include:


  • Market Analysis
  • Marketing Strategy
  • Patent Protection

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