Prescription Medicines
Our prescription team specializes in the development of CNS-active drugs, from traditional pharmaceuticals to psychedelics and cannabinoids. Whether you seek high-level strategic advice or hands-on team support, we have the clinical development, abuse potential assessment and regulatory expertise to help you both map and navigate the path forward.
EXPLORE OUR SERVICES
Regulatory Strategy
After decades of FDA and EMA interactions, our client-centered team understands exactly how to develop and support your product’s ideal regulatory strategy. You can embed us in your organization or retain us as outside experts. And, if you’re based outside the United States, you can rely on Pinney Associates to serve as your FDA U.S. agent.
- Fast track and breakthrough therapy designation requests
- FDA meeting planning, support, and participation
- IND preparation
- iPSP strategy and document preparation
- NDA preparation
- Orphan drug designation requests
- REMS and other postmarketing development and execution
- U.S. agent to FDA for foreign companies
Clinical Development
In recent years, the complexity of CNS-drug development has increased. Our experience has kept pace, enabling our expert teams to meet each new challenge. Today we’re standing by to provide the backup you need, whether it’s high-level strategy or boots-on-the-ground support.
- Abuse-related adverse event monitoring and evaluation
- Clinical development plans
- CRO and vendor selection support
- Clinical trial design, protocol writing, and support
- Due diligence and opportunity assessments
- Human abuse potential studies
- FDA meeting planning, support, and participation
- Target Product Profiles
Eight Factor Analysis (8FA)
An effective 8FA focuses on a novel product’s potential risks while highlighting its potential advantages for patients and the public health. Within the structure established by the U.S. Controlled Substances Act, Pinney Associates comprehensive 8FA development approach generates a benefit-risk assessment that supports the most appropriate drug scheduling for your product.
- Document development
- Down- or de-scheduling strategy
- New drug scheduling strategy
- Publication strategy
Abuse Potential Assessment (APA)
For more than 40 years, our internationally recognized experts have collaborated on developing assessment methods, and designing, conducting, and interpreting clinical and nonclinical abuse potential assessment studies. Along the way, our experts have worked for and with the FDA, the National Institute on Drug Abuse, and the College on Problems of Drug Dependence. Our expertise in developing APAs for CNS-active drugs is unparalleled. We take a comprehensive approach designed to help you achieve the appropriate scheduling for your product.*
- APA and eight factor analysis development
- APA strategy
- Nonclinical and human abuse potential (HAP) study designs
- FDA meeting support and participation
- Formulation assessment
- Gap analyses
- Labeling strategy
- Vendor selection
*If warranted under the U.S. Controlled Substances Act and international drug conventions.
Abuse-Deterrent Formulation (ADF) Evaluation
Regular engagement with FDA equips us with unique insights regarding in vitro ADF evaluations. This enables us to determine how to maximize your studies in ways that support approval and appropriate labeling.
- In vitro ADF evaluation protocol design and development
- Human abuse potential (HAP) study designs
- FDA meeting support and participation
- Gap analyses
- Regulatory strategy and comprehensive guidance
- Vendor selection
Postmarketing Surveillance and Risk Evaluation and Mitigation Strategies (REMS)
Our risk management expertise spans the preclinical and clinical development program through postmarketing activities across a broad spectrum of CNS-active drugs and other products.
- Comprehensive REMS assessment reports for FDA submission
- Strategic guidance on FDA interactions, including meeting preparation and participation
- Analysis and integration of data from multiple data sources
- Population health surveillance
- REMS development, amendment, and execution
- Survey development, data analysis, and reporting
Scientific Assessment and Review
Scientific rigor is fundamental to our work. We excel in providing you with comprehensive, science-based assessments—including safety, toxicology, clinical, and regulatory reviews—to support your clinical development projects.
- Competitive landscape assessment
- Due diligence and opportunity assessment
- Literature reviews
- Scientific dissemination
- White paper development
Target Product Profiles (TPP)
A successful clinical development plan must define project outcomes that demonstrate the benefits of your product over current standard of care or future competition. We can help you develop a strategic TPP that addresses unmet needs in the market to help ensure commercial viability.
- Competitive intelligence
- Indication selection
- Project TPP development
- Strategic TPP workshops
- Unmet need and market analysis
