CNS-Active Drug Products
CNS active dietary ingredients and cannabis derived products
YOUR NEEDS
- Selecting the most appropriate regulatory pathway for submission of your CNS-active botanical product (e.g. New Dietary Ingredient, traditional NDA, Botanical NDA)
- Due diligence related to your product, including relative potential for misuse, abuse, and diversion, and identification of factors that might lead to scheduling
- A prospective plan to manage emerging product safety concerns during development
- Help preparing for meetings with FDA
- Application for regulatory submission (NDIN, IND, NDA)
- Evidence-based rationale to support your product’s regulatory acceptance, based on the unmet needs of patients, benefits to the public health, and pharmacoeconomic considerations
OUR SERVICES
- Thorough abuse potential development plans for regulatory submissions to the FDA, EMA, Health Canada, and other regulatory agencies
- Preclinical study design and due diligence in collaboration with David Heal and colleagues at DevelRx, experts in evaluating the abuse and dependence risks of CNS-active products.
- Assessment of clinical trial data related to abuse potential, including study design and interpretation
- Comprehensive abuse potential assessment reports with scheduling recommendations (including DEA 8-factor analysis)
- Clinical development strategies to address key differentiating product attributes
- Support regulatory meetings from preparation to direct participation by world-leading experts
OUR EXPERTISE
- Behavioral & Clinical Pharmacology
- Clinical Drug Development
- Regulatory and Health Policy
- Data Management and Statistical Analysis
- Integrated Strategic Communications
- New Dietary Ingredient Notifications
Value to our clients
PinneyAssociates understands that development of CNS-active botanical products is a complex process defined by numerous , ever-evolving, regulatory, policy, and commercial issues. Our internationally recognized experts in public health, health policy, and abuse potential assessment provide clients with a comprehensive, evidence-based, strategy to identify the appropriate pathway for their products and achieve their regulatory goals.