Regulatory Strategy & Clinical Validation/Trials

Our Services include:

 FDA Regulatory Strategy:

1.Assessing the regulatory requirements applicable to your product

2.Developing a comprehensive regulatory strategy tailored to your specific needs

3.Meetings with the FDA and Notified Bodies

4.Preparing and reviewing regulatory documentation, including premarket submissions, 510(k) applications, and pre-IND packages

5.Conducting gap analysis and remediation plans to ensure compliance with FDA regulations

Clinical Validation Consulting:

1.Designing and implementing clinical studies to generate the required clinical data for FDA submissions or capital raise

2.Developing study protocols, informed consent forms, and case report forms

3.Assisting with site selection, site training and initiation, patient recruitment, and study monitoring

4.Preparing clinical study reports and assisting with FDA interactions related to clinical data
5.Building a clinical advisory board, KOLs and coordinating professionally with your KOLs and Clinical Advisory Board.

We understand the stringent regulatory landscape governing medical devices and pharma. Our experts ensure that AI solutions meet regulatory requirements, facilitating a smooth validation and approval process.

We believe that our expertise and comprehensive services can significantly contribute to the success of your FDA regulatory and clinical validation endeavors. We would welcome the opportunity to discuss your specific needs, challenges, and goals in more detail. Please let us know a convenient time for a call or meeting, and we will be happy to arrange it.

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AI &Innovation

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