FORMULA FOR SUCCESS
Biograph is future-focused with a bias for action. We design and implement solutions that meet regulatory requirements and empower individuals to make healthy decisions about their care.
Regulatory Approach: Engineered Self Care
The Biograph approach replaces chance with certainty and is the result of a decade of interaction with FDA as the Agency developed the new pathway for medication access under the rule for Additional Condition for Nonprescription Use (ACNU) and the new protocols for patient support under the Patient Medication Information (PMI) rule.
The Biograph ACNU Factory provides efficiency and resources to expedite ACNU development as part of the NDA program.
At Biograph, we begin with the end in mind. Our goal is always high performing, in-market products. When digital care is wrapped around a drug product, the intent is to improve outcomes. Our formula puts – and keeps – the consumer/patient at the center and ensures a strong value proposition for all stakeholders.
Quality & Scale
To report for Quality requires building for Quality.
Every drug approved by FDA carries a responsibility to report for quality. Biograph is a partner for domain expertise and unrivaled experience, plus connectivity to systems, data, digital capabilities and modern infrastructure that assures compliance with quality standards and post-marketing reporting.
Optimize Opportunity in Innovative Policy
The Biograph ACNU Factory
To jump-start ACNU product development, we’ve assembled all the necessary pieces for successful ACNU approvals in one place. We call it the ACNU Factory. Whether you’re beginning to explore ACNU or have a product ready to go, we’re here for you.
Challenges We Solve
Unpack the Policy and Assess Business Opportunities
Analyze and Prioritize Portfolio Scenarios
Develop Investment Thesis and Forecast
Align Systems, Data, and Services to Expedite Development
Build in Quality Assurance Processes and Reporting Protocols
Power for Cross-Channel Commerce and Speed to Market
How We Work
Bolt-On Capabilities to Support Client Team
Outsourced ACNU Expert Regulatory Team
Sponsored Product Development & Innovation Venture
Partnerships & Affiliations
Biograph works in partnership with Amwell
Since 2021, Biograph and Amwell have collaborated to bring digital care capabilities to Life Sciences applications, with a focus on regulated programs like ACNU. Working together, the Biograph and Amwell teams connect strategy with the data and digital care systems necessary for successful implementation and sustainable program performance at scale.
In partnership with Amwell, Biograph clients are able to access the digital capabilities of the Amwell Converge™ platform and apply them to support digital care initiatives.
Amwell is transforming hybrid care delivery, connecting and empowering providers, payers and innovators to improve outcomes and make care more accessible to all. Its cloud-based Converge enablement platform was designed to digitally enable a single, unified, scalable healthcare experience for in-person, virtual and automated care. The Converge platform provides the flexibility for clients to build their optimal hybrid care model and stakeholder experience – leveraging just one component or a combination of many components, all working together seamlessly across the platform.
About Biograph Inc.
Biograph is the premier hub for integrated capabilities, services, and technologies for high-performing digital care solutions.
Our expert team works across the pharmaceutical and consumer healthcare sectors to unlock new sources of growth and improve access with digital care solutions.
Ongoing interaction with FDA and industry experience has provided a unique perspective on the services and capabilities needed for the next generation of patient and consumer support.
FDA’s actions to advance digital labeling of both prescription and nonprescription drug products take PSPs and DFLs to a new level. We design digital solutions that meet regulatory requirements and will deliver commercial performance at scale.
Unlock Your Growth Potential
Our team of experienced consultants is ready to help you take your business to the next level.
Contact us today to learn more about how we can help.