Translational Science Solutions

Creative Solutions for Complex FDA Challenges

Charleston, SC

+1 843.779.5877

 

trans·la·tion·al sci·ence [noun]:  

a multidisciplinary form of science with the goal of “translating” advances in basic science knowledge into clinical healthcare applications

SERVICES

Translational Science Solutions specializes in navigating the complex FDA regulatory landscape for medical device and digital health companies. We understand that every product and company is unique, which is why we think creatively about the challenges you face. Our mission is to develop innovative, actionable strategies that accelerate your path to FDA approval. We offer:

1. FDA Strategy and Planning

We craft tailored regulatory strategies that align with your specific goals. Whether you're launching a new device or expanding into digital health, our approach ensures compliance while maximizing efficiency. We think beyond traditional routes, leveraging creative solutions that work for your unique circumstances.

2. Pre-Submission and FDA Interaction Support

Clear and effective communication with the FDA is crucial to a successful submission. We guide you through the pre-submission process, ensuring that your messaging is strategic and focused on long-term success. We help prepare meeting requests, organize FDA discussions, and ensure you are ready for each interaction.

3. Regulatory Submissions

From Breakthrough Device Designation (BDD) to Premarket Notification 510(k) and De Novo submissions, we develop regulatory filings that tell a clear story and serve as a foundation for regulatory success. Our innovative strategies reduce the likelihood of delays and streamline the approval process. Each submission is crafted to present your product’s value and safety in a way that resonates with the FDA.

4. Regulatory Risk Management and Reduction

Managing risks and maintaining compliance are central to our consulting services. We identify potential regulatory hurdles early, allowing us to solve problems before they become roadblocks. By thinking creatively, we can help you meet compliance requirements while supporting your broader business objectives.

5. Post-Market Marketing Compliance and Strategy

Our support doesn't stop after approval. We help you maintain compliance, develop post-market strategies, and manage FDA inspections or audits. By staying proactive, we help you mitigate risks and sustain success in the market.

Why TSS Consulting?

  • Creative Solutions: We think outside the box to overcome regulatory challenges.

  • Actionable Strategies: Our advice is practical and designed for execution.

  • Expert Guidance: We understand the FDA inside and out, ensuring your strategy is aligned with the latest regulatory developments.

  • Tailored Approach: Every product and company is different, and so is our approach to solving your regulatory needs.

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