Research Compliance & Consulting
Clinical research involving cannabis and cannabis-derived compounds is subject to significant regulatory compliance. At Robison Law, we recognize regulatory compliance as a critical component to your organization achieving success, and our attorneys are here to help you understand these regulatory compliance issues.
At all levels, the cannabis industry is subject to extensive regulation which may be unclear, confusing, or inconsistent. Meanwhile, businesses and organizations conducting research and the individuals involved pay a high cost for failure to comply. Our attorneys take the hard work out of compliance by providing you with critical advice and guidance, enabling you to navigate complex regulatory issues. Our attorneys not only assist you in understanding regulatory compliance and how to operate compliantly, but also advocate for your organization when working with government agencies regarding a compliance issue. We specialize in regulatory compliance at the local, state, federal and international levels in the cannabis space.
Our extensive local compliance experience ranges from identifying applicable regulations to working with city governments on relevant issues, such as building, zoning, and environmental considerations.
We are exceptionally skilled in working with state departments of agriculture, public health, environment, and revenue on both hemp and marijuana compliance matters. Additionally, we are well-versed in relevant state-by-state hemp regulations, programs, plans, and policies, and can provide the information you need to determine strategic operations and identify opportunities.
At the federal level, we are accomplished in working with a variety of agencies on regulatory compliance matters impacting businesses operating in the hemp space and businesses generally as employers.
Our hemp-specific regulatory experience includes working with the Drug Enforcement Agency (DEA) in a variety of matters, such as scheduled licenses-lab, manufacturing, import/export, and research & development, as well as other agencies and institutions such as the Food & Drug Administration (FDA), Institutional Review Boards (IRBs) operated by the Office for Human Research Protections (OHRP), Institutional Animal Care and Use Committees (IACUC), Customs and Border Patrol (CBP), the Federal Trade Commission (FTC), the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the National Institute of Health (NIH).
For all organizations, Robison provides crucial assistance in complying and working with agencies such as the Occupational Safety and Health Administration (OSHA), the Equal Employment Opportunity Commission (EEOC), and the Environmental Protection Agency (EPA), among others.
Our research compliance & consulting services include:
- Representing your organization in dealings with the FDA, IRBs operated by the OHRP, IACUC, and other agencies
- Assessing and advising on quality control and quality assurance plan
- Performing all manner of compliance assessments and drafting reports
- Advising on facility design
- Navigating the various cannabis-related clinical research licensing, certification, and related requirements
- Drafting compliance guidance documents, such as Standard Operating Procedures, Manuals, Workflow Tools (i.e., record-retention binders and templates, operational checklists, employee reference tools), and Employee Handbooks
- Conducting employee trainings
We have deep experience counseling on sophisticated transactional matters. Drawing on our expert knowledge of the cannabis industry, we advise clients from deal initiation through contract negotiation, review and drafting. Our core experience includes a wealth of work product on intellectual property and corporate deals.
Cannabis is a highly regulated industry, with rapidly evolving federal and state rules touching every aspect of our clients’ business. We offer up-to-the-minute knowledge of those regulations and we provide legally sound and practical advice on how to ensure compliance. With the enactment of the 2018 Farm Bill, compliance related to hemp, CBD and other cannabinoids remains nuanced and critical to your success.
Marijuana and hemp are growth industries that have attracted sophisticated investors, who require a detailed understanding of the field’s evolving legal framework before they commit financing. We counsel investors and prospective investors on the unique legal, financial, and tax issues that face cannabis businesses.