The lawyers at the Wood Burditt Group provide innovative, entrepreneurial and cost-effective solutions, which meet the needs of our clients in FDA-regulated industries. We offer comprehensive legal services to our clients in the areas of product development, regulatory policy, threatened enforcement and commercial transactions. We provide legal services involving bench, animal, preclinical and clinical testing. We offer legal services related to manufacturing, distribution, labeling, marketing, advertising and promotion. We deliver legal services related to exporting and importing drugs, biologics, medical devices, in vitro diagnostics, foods, dietary supplements and cosmetics. We also combine our scientific, technical, and business expertise to help clients address complex legal, regulatory, and scientific issues during the development, testing, and marketing of traditional and biotechnology-derived products.
Our clients range from start-ups to multinational corporations. They are manufacturers, distributors, importers, retailers and consultants in the medical device, diagnostic, biologics, food, food additive, dietary supplement and cosmetic business. Our client’s products are developed, handled, sold and used throughout the United States and the world.
We counsel clients on optimal strategies for obtaining FDA clearance and/or approval to investigate and market products. Our services include drafting or assisting with IND and IDE submissions; advising on clinical study designs; counseling on submissions for NDAs, ANDAs, BLAs, PMAs, and 510(k)s; preventing, mitigating and resolving pre- and post-approval GCP and cGMP compliance problems; counseling on licensing and outsourcing agreements that combine regulatory, intellectual property, and commercial issues; conducting due diligence on FDA and FTC aspects of public offerings, private placements, mergers, and product acquisitions; advising on compliance issues under USDA regulations; and general litigation and advocacy consulting before federal and state administrative, legislative and judicial bodies.