Government regulations govern almost every endeavor imaginable, from how products should be packaged and labelled, to how drugs should be approved prior to sale. Every endeavor faces a unique regulatory environment. Peacock Law attorneys know how to help you sort through the regulatory environment you face, to minimize your risk and generate value.
Biotechnology and Pharmaceuticals
Biotech and pharmaceutical products must comply with a myriad of complex regulations that can halt the commercialization of such products for years, particularly regulations promulgated by the Food and Drug Administration (FDA). Efforts to patent such products should be coordinated appropriately with the regulatory timeline so as to not lose patent rights. Peacock Law possesses the necessary subject matter expertise to decipher the complex regulations that govern these highly specialized fields of technology. We collaborate with, and advocate for, clients seeking patent term extension, or in processing Abbreviated New Drug Applications (ANDAs), as outlined in the Hatch-Waxman Law (the Drug Price Competition and Patent Term Restoration Act of 1984).
Natural Resource Extraction & Refinement
Back in the day, extracting natural resources was often as simple as staking a claim and beginning to dig. However, in the 21st century, mining coal and other minerals, or drilling for oil and natural gas, involves advanced technology – and strict environmental regulations. Possessing current knowledge of state, federal, and international regulations can mean the difference between smooth progress in a mineral retrieval operation – or being crippled with lengthy delays, or worse, having an entire operation ground to a halt. Peacock Law has assembled a legal team with both subject matter expertise as well as extensive understanding of relevant regulations.
Regulations and inventions developed in collaboration with the federal government are associated with unique regulatory and funding issues. Cooperative Research and Development Agreements (CRADAs), Small Business Investment Research (SBIR) grants, and similar federal-funding mechanisms, invoke regulatory issues, including the Federal Acquisition Regulations (FARs) and Defense Federal Acquisition Regulations (DFARs). The legal team at Peacock Law is well versed in the arcane jargon associated with government regulations, and helps our clients navigate the process toward a successful resolution.