Life Sciences - Regulatory Counseling and Compliance
Our longstanding in-depth experience with agricultural chemical companies, farm production, food, drug and industrial materials producers and manufacturers, as well as the health care industry, makes us uniquely qualified to assist in successfully navigating the regulatory morass. Our lawyers have extensive experience in managing and securing product approvals from the FDA (drugs, biologics, devices, foods and food additives), the EPA (pesticides and new chemical substances), and the USDA (plants and plant and animal pests), as well as the permitting, transportation, and import/export requirements associated with these various products.
Our strong practice in third-party payment issues for drugs and medical devices provides an essential component of any successful commercialization effort, given the critical role of such payment in commercial success. We also help our clients develop policies to ensure compliance with all federal rules governing research, such as lab containment, human subjects, special rules relating to recombinant research involving humans, animal welfare, environmental release, and experimental use permits and financial conflicts.
Representative Regulatory Counseling and Compliance matters:
- Advised infectious bacteria test kit company on regulatory requirements regarding relocation and transportation of microorganism banks
- Advised range of companies on EPA requirements for registration of biopesticides and antimicrobial pesticides, and engineered strategies for expediting same
- Represented farm producers and associations on emerging environmental impacts of on-farm agribusiness in regulatory negotiations and litigation under the Clean Water Act and the Clean Air Act