PRESCRIPTION

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
  • Development plan for and due diligence of animal and human abuse potential studies, in collaboration with RenaSci and other selected expert study providers
  • 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

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.