PRESCRIPTION & OVER-THE-COUNTER

Pharmaceutical risk management

YOUR NEEDS

  • 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)

OUR SERVICES

  • 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

OUR EXPERTISE

  • Regulatory and Health Policy
  • Clinical and Behavioral Research
  • Data Management and Statistical Analysis
  • Integrated Strategic Communications

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.