Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces the firm’s complete portfolio of services to support companies developing, commercializing, utilizing, and investing in innovative digital health technologies.
“Players in the digital health space face unique challenges in navigating an ever-changing regulatory landscape, as FDA regulators try to keep up with the pace of digital health technology development,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs. “Greenleaf serves as a trusted partner to both large and small clients developing and commercializing innovative digital health technologies as they navigate the complex landscape of FDA regulations and policies.”
STRATEGIC & TECHNICAL GUIDANCE
Greenleaf professionals work as teams specializing in medical devices and combination products; product quality, manufacturing, and compliance; and drug and biological products. Greenleaf’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges. Greenleaf offers the following digital health-focused services:
Regulatory Strategy & Compliance
Greenleaf experts provide insight, clarity, and strategic consultation on digital health topics. Regulatory strategy and compliance services include:
– Advise clients on FDA regulatory policies, programs, and procedures, including questions related to jurisdiction to regulate, device classification, and potential pathways to market
– Partner with clients to design strategies for product development and premarket review
– Assist with marketing application preparation and submission
– Provide advice regarding FDA communications, including compliance and regulatory correspondence
– Advise on FDA labeling and postmarket safety requirements
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Advisory Services
Greenleaf professionals assist entities involved in digital health technology investments and transactions. Advisory services include:
– Perform due diligence and regulatory risk assessments of potential targets
– Advise investors on opportunities to manage and mitigate risks in order to achieve desired regulatory outcomes
– Research and analyze regulatory data sources
Regulatory Policy
Greenleaf’s cross-functional teams help clients keep pace with developments and navigate the emerging regulatory landscape. Regulatory policy services include:
– Identify novel regulatory tools and approaches to optimize the development process
– Support clients in structuring their regulatory policy capabilities to effectively advance priorities
– Design and implement strategies that engage stakeholders, leverage alliances, and advance regulatory policy
AREAS OF EXPERTISE
Greenleaf’s team of experts provides guidance to medical device and combination product manufacturers, pharmaceutical and biotechnology companies, trade associations, and other stakeholders implementing and complying with the FDA’s digital health requirements. Because there is no one-size-fits-all approach, each solution is built to fit the targeted needs of the client. Greenleaf regularly provides expertise to the following types of clients:
– Start-up and mid-size software companies developing digital health mobile apps
– Drug companies entering the digital health space to enhance the patient or health care provider experience of their products
– Diagnostic testing companies developing applications to read diagnostic test results
– Consumer product companies entering the digital health space with limited FDA regulatory experience
– Investors identifying and evaluating regulatory risks in potential digital health investments
– Trade associations and global drug and medical device companies developing digital health policy strategies
– Artificial intelligence (AI) program developers seeking FDA regulatory insight and clarity
– Telehealth companies partnering with clinical practitioners and life science companies to offer online access to medical products
– Health policy and research organizations developing, tracking, and responding to digital health policies, legislation, and initiatives
– Drug and device companies using digital tools to conduct decentralized clinical trials