OVER-THE-COUNTER

OTC product stewardship

YOUR NEEDS

  • Develop and execute a strategy to explain and enhance an approved OTC product’s benefit/risk
  • Build the benefit/risk case for an approved OTC product or class of products

OUR SERVICES

  • Develop a compelling science-based public health rationale for an approved OTC product
  • Assess the scientific and public policy environment to inform an engagement strategy and stakeholder outreach
  • Prepare scientific literature reviews of an approved product’s pharmacology, safety, and other relevant data
  • Develop specialized behavioral research and consumer trials to understand real-world product use and support an approved OTC product
  • Help sponsors prepare for meetings with regulators, other policy makers and stakeholders, including preparing reports, presentations and manuscripts
  • Develop and help execute an engagement strategy for stakeholder outreach

OUR EXPERTISE

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

The regulatory, scientific and public health policy environment shifts over time, and can leave approved OTC products vulnerable on multiple fronts. PinneyAssociates’ experts have decades of experience engaging with regulators, policy makers, scientists, and public health professionals to support OTC products. We understand the importance of understanding and building the scientific foundation to support an OTC product and the importance of responding to stakeholders’ concerns.