Regulatory Law

Meet our new Regulatory & IP Attorney:

Biotechnology Patents Chemical Patents Software and Business Methods Patents Licensing Regulatory Law

Cassie J. Edgar

McKee, Voorhees & Sease is thrilled to provide its clients a level of protection for their products that is unlike any other in that of FDA, USDA, and EPA regulatory and product development law.

Regulatory counseling is critically important to be coupled with intellectual property solutions for product development & commercialization of regulated products from initiation through post-launch phases. In regulatory law, the goal is to demonstrate substantial equivalence and a lack of differentiation to other existing products. In contrast, proving novelty and non-obviousness over existing inventions is foundational to secure patent protection. Careful coordination of these legal strategies and related public communications is fundamental to business success.

Cassie J. Edgar, Chair of the Regulatory & Product Development Law practice group, brings decades of in-house counsel IP and regulatory experience, both US and global. Intellectual property focuses on everything from freedom-to-operate to patent strategy and enforcement. Regulatory law concentrates on regulatory approvals, stewardship, and compliance. Cassie’s goal is to help clients through both IP and Regulatory decisions that best fit their business goals whether that be on a local, national, or global scale.

Cassie’s specialty practice includes:

Global intellectual property including patent prosecution, patent marking, enforcement, licensing, and litigation. Litigation may encompass anything from IPR/PGR/federal litigation support, and coordinating global revocation and opposition proceedings.  

Global regulatory law including managing biotechnology communications & crisis management, compliance, stewardship, regulatory data package generation, and obtaining regulatory permits and approvals with USDA, FDA, EPA and global regulatory agencies necessary for U.S. sales.

Product Development strategic planning across plant and animal industries including stages & gateways management, portfolio management, project management, and launch & post-launch planning integrating IP & regulatory solutions.

Business Development including developing legal solutions for your business with the specific needs of regulated products in mind, coordinating business, IP and regulatory requirements during the startup phase and discovery research, subsequent funding rounds, licenses, JVs and M&A activity.

 






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