Rx-to-OTC Switch Innovation and Digital Self Care


Accelerate growth with next generation nonprescription products and connect with consumers using a newly validated digital health approach

Unlock Revenue with New Products and Chronic Categories

Speed to Market,
Improved PRS,
Lower Investment

Gain Brand Exclusivity and Direct Consumer Relationships

Get Real-Time Data
and Insights and Generate RWE

Biograph Powers Digital Self Care

  • Digital Labeling
  • Digital Algorithms
  • Data Interoperability
  • Objective Verification
  • Real World Use
  • Direct Consumer Connections

Designed to Meet FDA Requirements

DFL-Derivative Algorithm is a trademark of Biograph Inc.

Enabling Self Care Transformation

With a decade of research and development in nonprescription access, Biograph understands the complexities of regulatory, technical and commercialization requirements in this new market space. We bring advisory and patent-pending process to a pathway forward for product approvals in new drug categories.

Featured Resources

March 2019, PwC identifies four major FDA regulatory changes to digital health that are driving substantial new opportunities to market new products and connect with patients (consumers).

Digital Switch is among those opportunities, and PwC forecasts the immediate benefits to include:

SPEED: “get products to market more quickly”

SALES: “increase market share”

SUSTAINABLE ADVANTAGE: “create ties that go beyond the pill”


FDA Draft Guidance for Industry Innovative Approaches
for Nonprescription Drug Products

On July 13, 2018, FDA released guidance to industry regarding innovative approaches for nonprescription drug products. In that guidance, the Agency asserts regulatory authority over additional labeling, additional conditions and proper implementation for consumer access to a new generation of Digital Switch.


Reveal the Future of Healthcare

Healthcare consumer expectations for digital access to care and therapies are on the rise. Convenience, cost and control of healthcare options are all important to today’s consumers. Consumers of all generations are more willing to try digital, non-traditional services. Leading companies will heed this shift and will navigate the future as healthcare consumerism unfolds.


Regulatory Advisory to Ensure Alignment with FDA Guidance on Innovative Approaches

Technical Pathways and Patent-Pending Processes to Ensure Proper Implementation

Commercialization Insights to Optimize Sustainable Growth



Rx-to-OTC Switch Innovation and Digital Self Care

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