Biotechnology is as complex as it is essential, and almost every phase of its operation is rooted in science. As many of our clients can attest, stand-alone legal advice or technical consulting typically offer incomplete solutions and perspectives. The strong collaboration of law and science at Keller and Heckman positions us to guide our clients toward effective regulatory solutions to bring products into the market.
Established companies and start-ups alike must pass a variety of regulatory reviews to secure the necessary approvals to market their new technologies. Our wide-ranging experience provides Keller and Heckman's clients with effective access to government agencies, international organizations, and industry trade associations, to help achieve their objectives. Keller and Heckman provides creative and streamlined regulatory strategies in the following areas and helps clients navigate the global marketplace.
- As a top-of-mind firm in Food and Drug Administration (FDA) requirements, clients with new technologies used to produce substances with uses in food, food packaging, animal feed, drugs, or medical devices have the benefit of our experienced advice.
- The firm has pioneered ways to achieve pesticide registrations and exemptions from tolerance for groups of new and related products.
- A private party expert on the chemical nomenclature policies of the Toxic Substances Control Act (TSCA) and the Chemical Abstract Service (CAS), Keller and Heckman is well-equipped to help emerging technologies in industrial chemicals through TSCA's requirements.
- Keller and Heckman has alliances with capital formation ventures and negotiates bank, venture capital and vendor financing. Our business group services an important mix of contracts and other transactional matters involving intellectual property (IP) rights.
- We provide expert IP counsel on how to supplement patent protection for emerging investments and maintain a corporate environment that guards trade secrets. Patent prosecution is a crucial consideration and the firm has a number of patent firms with whom we cooperate. We also litigate patent and product liability claims.
- With our synergistic blend of in-house scientists and attorneys, we help companies approach Occupational Safety and Health Administration (OSHA) hazard assessments and workplace compliance for bio-based and nano-materials both scientifically and legally.
Our attorneys and scientists are members of the Virginia Biotechnology Association, the Biopesticides Industry Alliance, and the California Technology Advisory Committee.
Keller and Heckman has a proud and successful history of counseling clients and associations on the requirements for communicating with regulators and the public concerning the health, safety, and environmental considerations of emerging technologies. We open markets and help keep them open.