Submission Service

EMPOWER's Regulatory Submission Service offers end-to-end support to streamline your medical device's journey to market.

The Value

Of an EMPOWER Submission

  • EMPOWER’s in-depth review of all submission documents ensures adherence to the high standards expected by regulatory bodies. This diligent preparation minimizes the risk of issues, facilitating a more efficient submission and reducing potential delays or additional costs.

  • With EMPOWER managing your regulatory submission, you can be reassured that the regulatory complexities are being handled with care and diligence. This partnership allows you to maintain focus on your core business activities.

  • Leverage EMPOWER as a liaison between your company and regulatory bodies. This service ensures that your communications are clear and effectively managed, streamlining the submission process and fostering positive relationships with regulatory authorities.

What’s Included?

  • Submission Readiness Assessment: Review the regulatory strategy and ensure all necessary data and documentation are in place for submission.

    Documentation Audit: Conduct a thorough review of all technical, clinical, and administrative documents to ensure completeness and compliance with regulatory requirements.

    Timeline and Milestone Planning: Establish a detailed submission timeline, aligning with the client's business goals and regulatory deadlines.

    Regulatory Authority Meeting: Meet with regulatory authorities to ensure alignment on expectations for your device.

  • Application Compilation: Assist in compiling and organizing the submission packet, including technical dossiers, clinical data, and administrative forms.

    Quality Assurance Review: Implement a rigorous quality check to ensure that all documents adhere to regulatory standards and guidelines.

  • Regulatory Authority Liaison: Act as the intermediary between the client and regulatory bodies, managing all communications and submissions.

    Submission Tracking: Monitor the progress of the submission, keeping the client informed at every stage.

  • Response Preparation: Assist in preparing responses to any queries or requests for additional information from regulatory bodies.

    Amendment Management: Help in making any necessary amendments to the submission documents, based on feedback from regulatory authorities.

    Approval Tracking: Keep track of the approval process and notify the client upon receiving market authorization.

Get Started

To get started with EMPOWER on your regulatory submission, fill out the following form and you will be contacted within 48 hours. We look forward to partnering with you!