Pharmaceutical risk management
- Prepare a comprehensive risk assessment for an Rx or OTC product
- Develop and execute a risk management plan or Risk Evaluation and Mitigation Strategy (REMS)
- Provide expert guidance on appropriate risk management steps for Rx and OTC products
- Develop comprehensive benefit-risk analyses for new chemical entities
- Assess potential for misuse and/or off-label use, and relative risk for nonmedical use, misuse and abuse among specific populations
- Develop and assess risk management tools
- Manage expert advisory boards on a range of topics, including abuse liability, product safety, and appropriate use
- Support regulatory meetings from preparation to direct participation by world-leading experts
- Regulatory and Health Policy
- Clinical and Behavioral Research
- Data Management and Statistical Analysis
- Integrated Strategic Communications
Value to our clients
PinneyAssociates is a recognized leader in pharmaceutical risk management. Our risk management experience spans pre-launch, launch and post-launch activities across a broad spectrum of products including those with restricted distribution, limitations on prescribers and dispensers, as well as all levels of controlled substances and all types of over-the-counter products, and hospital-based products.
Our experts regularly interact with and advise U.S. and international regulatory and independent organizations including: the FDA, DEA, NIDA, SAMHSA, Congress, WHO, FDLI, as well as the College on Problems of Drug Dependence and the American Pain Society.