#1 recommended consultants for Rx–to– OTC Switch*

Since our founding in 2011, SBL Consulting Group has worked on 50 Rx-to-OTC switches, including switches approved in 2020 and 2023. Among other initiatives, the team has led the strategy, planning and program implementation of multiple first-in-class Rx-to-OTC switch candidates. SBL Consulting Group has also helped Pharmaceutical companies succeed in the OTC space after approval. For example, the team has helped build internal and external capabilities in the OTC retail and DTC markets. The team has also developed and executed marketing plans for switch brands after FDA approval.

We have a passion for ensuring safe access to a greater range of self-treatment options in the US.

Susan B. Levy, Founder and Principal of SBL Consulting Group, is widely regarded as one of the leading industry experts in the US on the topic of Rx-to-OTC switch. She has presented and led workshops at numerous Rx-to-OTC switch conferences internationally and for the Consumer Healthcare Products Association (CHPA).

How we can help

if you are considering an Rx-to-OTC switch project, here’s what we have done:

  • Led the strategy, planning and program implementation of multiple first-in-class Rx-to-OTC switch candidates from both a regulatory and commercial perspective
  • Created Drug Facts Labels
  • Drafted Consumer Information Leaflets
  • Engaged with CROs for required Rx-to-OTC switch studies
  • Created and supported OTC launch plans
  • Assessed Rx-to-OTC switch and Direct-to-OTC potential for multiple candidates
  • Market Analysis
  • Current and Future Competitive Analysis
  • Pricing Analysis
  • Market Research
  • Forecasting
  • Assisted Rx companies with Rx-to-OTC switch outlicensing strategies
  • Supported top ten consumer healthcare companies’ efforts to evaluate and secure in-licensing candidates in various therapeutic categories
  • Accelerated timelines for existing Rx-to-OTC switch programs
  • Contributed to the Rx-to-OTC switch evaluation process for OTC and Pharmaceutical companies
  • Helped companies new to the Consumer Health space evaluate go-to- market strategies and develop capabilities to achieve retail and ecommerce goals

“

Switch provides a unique mechanism to launch a new-to-the-world consumer healthcare product. But if you have seen one switch – well, then you have seen one switch. Every Rx-to-OTC switch has a unique set of challenges, often at different points along the pathway from development to commercialization. Our team has deep expertise along the switch process continuum and understands that maximizing commercial potential requires early development plan input.

Susan B. Levy

Founder and Principal

Rx-to-OTC Switch Thought Leadership and Education

The SBL Consulting Group team members have:

  • Been invited to serve as a Board Member of the Consumer Health Care Products Association (CHPA) in addition to contributing to the CHPA Rx-to-OTC Switch internal working group
  • Presented and led workshops for self-care companies and at numerous Rx-to-OTC switch conferences domestically and internationally
  • In partnership with the Consumer Healthcare Products Association, commissioned primary research to better understand consumer attitudes and expectations about Rx-to-OTC switch
  • Provided Thought Leadership in publications and conferences about the impact of FDA’s ACNU decision for switches as well the impact of digital health technology on ACNU
  • Written articles on Rx-to-OTC switches
  • We literally “wrote the book” on switch: two pivotal chapters in “Lifecycle Management through the Rx-to-OTC Switch”, published by the Regulatory Affairs Professionals Society, September 2021
*Sourced from Google AI Assistant and ChatGPT in February 2025

SBL Consulting Group, LLC
184 North Avenue East, Second Floor
Cranford, NJ 07016

908-654-1054 (office)
info@SBLConsultingGroup.com

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