Address FDA requirements faster 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.

Focus Areas

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 enitities

  • 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

These innovative products, whether a single entity or co-packaged for convenience, require specialized expertise in navigating regulatory requirements for successful development and market entry.

A drug device combination product is an innovative solution that integrates pharmaceuticals, medical devices, 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 the development, approval, and successful market entry of these cutting-edge combination products.

Connected IoT Medical Devices

Connected medical devices, sometimes called IoT medical devices, are increasingly desired in modern care management processes.

Edaphy can help with all aspects of planning, development, and testing, including:

  • Design History Records

  • Cybersecurity

  • Quality Management Systems (QMS)

  • Human Factors Testing

  • Verification and Validation

  • Contract Manufacturing Management

Human Factors and UX

The FDA requires human factors testing for medical devices and drug-device combination products.  Edaphy ensures that your products are user-friendly, reliable, and compliant with human factors principles and regulations.

Our human factors testing services:

  • Reduce user-errors

  • Increase prescriber acceptance

  • Meet FDA expectations

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 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

Quality and compliance is relevant for a wide range of products regulated by the FDA, including pharmaceuticals, medical devices, nutraceuticals, and food and contract manufacturing industries.

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

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