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Regulatory Service

What we bring to the table:

  • Act as a regulatory representative with FDA and other regulatory agencies.

  • Meet with regulatory agencies on behalf of our clients and manage the pre-submission program, informal guidance, or formal guidance meetings.

  • Prepare regulatory applications for Class II or Class III devices for FDA or for international regulatory agencies.

  • Prepare regulatory strategy and gap analysis.

  • Prepare Investigational Device Exemptions (IDEs).

  • Prepare Pre-market Approval Application (PMA).

  • Prepare Notification (510(k)).

  • Prepare Humanitarian Device Exemption (HDE).

  • Review product and manufacturing changes to ensure compliance with applicable regulations.

  • Review protocols and reports that support regulatory submissions.

  • Collaborate with your team to support product release process.

  • Communicate regulatory requirements and the impact of regulations to the product development team.

  • We have knowledge of current domestic and international medical device regulations, to ensure submission requirements world-wide meet the current regulations.

Doctor Using Digital Tablet

BIOTOX Consulting Services, LLC will manage the Lifecycle of your regulatory process.  From early-stage development through the approval and commercialization of your product, our consultants will assist with all your regulatory needs across the entire product lifecycle.


BIOTOX Consulting Services, LLC interfaces with your team early in the product development process to communicate regulatory requirements and the impact of regulations to the development team.  We use our expertise to manage and guide the regulatory aspect of your company so that you can focus on developing life-changing products.


Let BIOTOX Consulting Services, LLC help you streamline your regulatory process.  Contact Us for a consultation today.

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