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.