Simplifying the Regulatory Review Cycle for Combination Products

Preparing your device for regulatory review can be overwhelming, if you don't speak the language of devices. EdgeOne Medical brings deep regulatory expertise, ensuring your combination product is represented effectively for a smooth approval process.

Authoring the Device Story

The success of your regulatory submission depends on presenting the device data in a way that addresses and demonstrates performance, safety and compliance to the device regulatory reviewers. At EdgeOne Medical, we help ensure the device portion of your submission speaks directly to the device regulatory reviewer. By showcasing the integrity and compliance of work performed, we help streamline the agency review process.

Critical Elements of a Successful Submission

Appropriate design input requirements and acceptance criteria
Identification and discussion of product risks: Essential Drug Delivery Outputs (EDDO)
Presentation of technical data supporting performance over intended shelf life

Combination Product Regulatory Support Services

From authoring device portion of your IND, BLA or NDA submission to assessing gaps in your documentation, EdgeOne Medical’s team of experts is with you every step of the way, ensuring you are submission ready!

Device Submission Authoring

We take ownership of authoring the device portion of your regulatory submission, applying the language of devices to tell your device story.

Your submission will address all critical elements of a device submission to streamline the agency review process.

Regulatory Guidance Throughout Development

EdgeOne Medical partners with you from the start of your device development, providing clarity and ongoing regulatory guidance.

This ensures that your device development stays aligned with the regulations, reducing the risk of delays and streamlining the path to submission and approval.

Regulatory Filing Gap Assessment

If your program was developed outside of EdgeOne Medical, our experts are available to provide an independent assessment of your technical documentation before you author your submission.

We help identify potential gaps that could pose a risk to the submission review process.

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The EdgeOne Advantage

With more than 60 regulatory submissions under our belt, EdgeOne Medical regulatory experts are not only well versed in authoring submissions they are also cross-trained device development engineers. As such, they have direct experience on how the device development process works and what technical data and documentation is generated at each stage of the process.

With this cross functional experience, we help you avoid common pitfalls in regulatory submissions and move confidently through the submission review process.

Common Regulatory Questions

We know that navigating device regulations can feel complex. Here are some of the most common questions we hear from emerging pharma companies.

: The answer is yes, regardless if the device is or isn’t one of the topics on which you are seeking guidance from FDA. You should describe your delivery device to give the FDA a complete understanding about the drug/biologic use case and how it will be administered to deliver the therapy. In addition to describing the device, you should also provide a brief overview of the device development activities you are performing according to 21CFR820.30.
: In general, the device content needed is dependent on if the submission is for clinical use or marketing authorization. For a clinical submission, device information, including device characteristics affected by the use of the device with the drug/biologic, must demonstrate that the device is safe and effective for its intended use in the planned study. For marketing authorization, the submission requires additional information, including demonstration of control in production to ensure the product meets its intended performance, safety, and efficacy. The specifics of what you need for your submission should be outlined in your device regulatory strategy. Not sure what’s next? We’re here to guide you—contact us for expert advice.

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