Regulatory Compliance for Life Sciences
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.
Our Work Includes:
- Finance Advised on early round capital raising for startups, and all manner of healthcare finance issues for entrepreneurial ventures.
- Health Technology Structured health technology business models to comply with healthcare laws and regulations and advised on business plan development and regulatory issues.
- Licensing and Product Agreements Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for biologics, and related products.
- Life Sciences Our life sciences experience includes work for pharmaceutical and biologics companies.
- Marketing Campaign Compliance Evaluated biotechnology company marketing campaign for compliance with the federal Anti-Kickback statute and other fraud and abuse laws.
- Program Development/HIPAA/Privacy and Information Security Counseled companies in clinical trials, technology start-ups, others on HIPAA and state health information privacy laws and development of privacy compliance programs.
- Regulatory Compliance Counseled on all regulatory aspects of healthcare, including for pharmaceutical, manufacturing, and related clients.
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.
Our Work Includes:
- Program Development Counseled clinical trials companies on HIPAA and state health information privacy laws and development of privacy compliance programs.
- Regulatory Leadership We play a leadership role in regulatory compliance, guiding clients on risk avoidance and the essential challenges implicit in the development of new health technology, medical device, pharmaceutical and digital health-related products and services.
- Telehealth Advised telehealth provider utilizing proprietary technology and clinical protocols to deliver standardized, ultra low-cost care hyper-efficiently, leveraging clinical intelligence embedded in the technology.
- Telemedicine and Healthcare Technology Advise telemedicine and other health care technology clients on clinical trial development, providing expertise on telemedicine, fee splitting, anti-kickback, and other healthcare regulatory issues.
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.
Our Work Includes:
- HIPAA and Data Privacy/Security Laws Advised medical device companies on HIPAA and other health data security and privacy matters and development of privacy compliance programs.
- Licensing and Product Agreements Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for medical devices, and related products.
- Life Sciences Our life sciences experience includes work for medical device companies.
- Marketing Campaign Compliance Evaluated medical device company marketing campaigns for compliance with the federal Anti-Kickback statute and other fraud and abuse laws.
- Strategic Consulting Our work encompasses strategic consulting for medical device manufacturers, including significant lobbying and governmental representation experience.
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.
Our Work Includes:
- California Board of Pharmacy Defended a Board of Pharmacy action involving enteral nutrition (infant formula) products.
- FDA Compliance Utilized collaborative relationships with leading Washington, D.C. FDA boutique firms for federal lobbying and submission purposes.
- FDA Investigations Defended FDA investigations of a dietary supplement manufacturer.
- FDA Requirements Advised an online start-up medical food business on compliance with FDA requirements.
- Intellectual Property Engaged in trademark disputes involving nutraceuticals.
- Litigation Advance and defend nutraceutical clients before courts and federal and state enforcement officials, including the FDA and California Board of Pharmacy.
- Regulatory Compliance Audited a physician group to ensure compliance with federal and state requirements in nutraceuticals sales.
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.
Our Work Includes:
- Broad Spectrum of Issues Our experience includes work for pharmaceutical companies across a broad spectrum of traditional and emerging healthcare issues.
- Licensing and Product Agreements Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for pharmaceuticals, biologics, and related products.
- Regulatory Compliance Counsel on all regulatory aspects of healthcare for pharmaceutical, biologic, laboratory, and related clients.