Regulatory Affairs and Patent Management

TCG has significant experience in developing and implementing patent and regulatory strategies that support a company’s overall business goals.  Our experience includes veterinary biologicals, therapeutics and medical devices, as well as human medical device and pharmaceutical regulations. Recently, TCG assisted a medical device company in expanding its products to the veterinary field, taking advantage of a cost effective and rapid regulatory process.

Although TCG is not a regulatory consulting firm, we work with and manage expert regulatory consultants in all of the key technologies and markets.  We aim to develop regulatory strategies that support business objectives while minimizing risk and controlling cost. This can be particularly helpful for non-US firms who often need ‘on the ground” coverage.

Similarly, our TCG Team has extensive experience dealing with intellectual property and patent attorneys to devise effective plans that capture the value of technological innovation and maximize the interests of potential partners.

When partnering with European companies, you must be aware of the culktural differences. An interview with Dr. Bob. Keefer, originally published in the Triangle Tech Journal, gives valuable hints.

"Commercialization is all part of brand management, how you build a brand. The companies who specialize in this may prove very helpful" says Dr. Robert Keefer. Read "Companies Supporting Other Companies" from The State of Life Sciences in North Carolina (Supplement) in The Scientist.