Address FDA requirements faster and with confidence
The Edaphy team has years of experience navigating FDA pathways and regulated product development. We help at every point of the idea-to-approval journey for drugs, devices, and drug-device combination products.
Make sure-footed progress with Edaphy
Most consultants and CDMOs can suggest a few steps forward, but this can lead to a dead end if the full landscape is not well understood.
Edaphy can speed your journey forward. We are regulatory experts, engineers, physicians, researchers, and entrepreneurs who have built regulated products and successful businesses.
Regulatory and Reimbursement Strategy
Navigating regulatory pathways can be a daunting task. Leverage our experts to optimize your strategy and meet regulatory requirements efficiently.
Regulatory pathways we focus on:
505(b)(1) for new drug entities
505(b)(2) for combination products that include a mix of drugs, devices, software, and tests.
505(j) for ANDAs
510(k) for medical devices, especially connected devices and their associated cybersecurity and data regulations.
Combination Products
Specialized expertise in navigating the requirements of CFR 21 Part 4 for development, submission, and market entry.
Drug-device combination products can integrate pharmaceuticals, medical devices, software, and/or biological products to address specific therapeutic or diagnostic needs. Our expertise lies in navigating the complexities of these products, whether they are a unified single entity, co-packaged for convenience, or cross-labeled for synergistic use.
We guide clients through the regulatory landscape, ensuring compliance and facilitating development, approval, and successful market entry.
Connected Medical Devices
Connected medical devices, sometimes called IoT products, are increasingly desired in modern care management processes.
Want to start near the finish line?
Leverage our FDA-compliant connected medical device platform. Use as a reference design or modifiable system.
Edaphy can help with all aspects of planning, development, and testing, including:
Design History Records
Cybersecurity
Quality Management Systems (QMS)
Verification and Validation
Contract Manufacturing Management
Manufacturing and Packaging
Edaphy serves as a “virtual CDMO” by managing best-in-class production partners via a consistent and compliant approach to quality and event management.
Our experts and network of manufacturing and packaging partners can handle a wide variety of needs. Importantly, Edaphy provides the quality management layer that allows for the efficient and flexible creation of regulated products.
Advantages of Working with Edaphy:
Expertise with quality management throughout the production chain
Greater flexibility to optimize vendors to improve costs and/or volumes
Active oversight and follow-up
Quality and Compliance
Edaphy specializes in:
FDA-compliant quality system creation and maintenance
USP, ISO, EU, and ASTM compliance
Audit management, responses, gap analyses, deviation investigations, and CAPA