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