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,
Gain Brand Exclusivity and Direct Consumer Relationships
Get Real-Time Data
and Insights and Generate RWE
Biograph Powers Digital Self Care
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.
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FDA Draft Guidance for Industry Innovative Approaches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
GO DIGITAL. GET GROWTH!