Regulatory compliance presents the biggest hurdle for life sciences companies. Nelson Hardiman attorneys advise these businesses on Medicare, U.S. Food and Drug Administration (FDA), HIPAA and clinical research compliance. We have defended numerous investigations relating to compliance and fraud and abuse issues. Our strong experience gives us the in-depth understanding to assist clients in product development and regulatory approval, including issues related to third-party payor reimbursement across the life sciences industry.
Our clients include medical device manufacturers and resellers, biotechnology companies developing new drugs, biologics, medical foods, and other therapies, and manufacturers and resellers of “nutraceutical,” “cosmeceuticals,” and supplements. We leverage our regulatory know-how to help clients develop and maintain regulatory compliant life sciences companies. Clients count on Nelson Hardiman to make sure their businesses are protected from regulatory risks and to help structure dynamic new business ventures.
Nelson Hardiman is a leader in the rapidly expanding biologics industry. We navigate the significant regulatory, intellectual property and business challenges of biologics, which represent many of the most promising new treatments for cancer and other major diseases. Our focus on healthcare innovation magnifies our strong interest in biologics and our awareness of the costly technologies and the manufacturing techniques needed to produce biologics, as well as the urgency to market these treatments.
Our experience encompasses the regulatory pathways for biologics and biosimilars created by the Biologics Price Competition and Innovation Act (BPCIA), as well as FDA, state and local regulations, intellectual property and business concerns. We have deep insight into the regulatory landscape, unique strengths in innovative healthcare finance, and a commitment to revolutionize the battle against challenging diseases through biologics.
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At Nelson Hardiman, we see clinical research as the place where innovation can thrive, centered on initiatives to move medicine forward. We apply our healthcare industry experience to navigating the legal considerations and regulatory compliance issues required to set up, monitor and complete a clinical research trial.
Our team of healthcare-focused attorneys have advised extensively on the federal anti- kickback statute and IRS requirements, and on the implications for clinical trials. We counsel clinical trials companies on the development of clinical studies that comply with HIPAA and state health information privacy laws, negotiate contracts, and set up monitoring and auditing standards that comply with federal, state and local regulations. Nelson Hardiman can guide your clinical research trial every step of the way from inception to completion.
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At Nelson Hardiman, we understand that FDA regulatory compliance is the key to success for medical device companies. Our strong healthcare regulatory experience helps our clients navigate the competitive and evolving industry. From our catbird’s seat we keep an eye on the future for medical device technology and innovation, prepared to problem-solve the next legal challenge.
From 3D bioprinting of human tissue and smart probes/smart scalpels to electromagnetic acoustic imaging, wideband medical radar, and nanbots, we keep our finger on the pulse of emerging medical device technologies and industry developments. We are constantly creating, innovating, and enhancing business, litigation, and regulatory strategies to keep our clients at the forefront of change. We apply our industry-leading experience to help medical device companies resolve legal challenges as they explore and conquer new frontiers in medical device advancement.
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Driven by a paradigm shift in lifestyle trends and health habits, the expanding market for nutraceuticals/dietary supplements is balanced by regulatory pressures and headline-grabbing intellectual property/trade secret, and litigation issues. Nutraceutical companies choose Nelson Hardiman as their business and litigation counsel because of our broad healthcare capabilities and our deep commitment to transformative innovation and entrepreneurial opportunities.
Our healthcare-centric attorneys understand the nuanced complexities of FDA and DSHEA regulatory requirements, advising nutraceutical manufacturers and resellers in California and nationwide. We counsel established and emerging nutraceutical businesses on strategic considerations, regulatory concerns, intellectual property and other legal issues, actuating our clients’ success in one of the fastest-growing healthcare sectors.
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Our vast healthcare experience and deep pharmaceutical industry knowledge helps our clients navigate this competitive and highly regulated industry. With an eye on the future of healthcare innovation, we diligently track the regulatory landscape and emerging industry trends, focused on legal protections related to the development of pharmaceutical products and services.
We apply decades of experience with healthcare regulations, finance and innovation to the key issues of concern to pharmaceutical companies. In a multi-billion dollar industry fueled by pharmaceutical discoveries, advances in biomedical research, and prescription e-commerce, Nelson Hardiman protects the high-stakes interests of our pharmaceutical clients.
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