CLINICAL TRIAL SERVICES

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• Research & Development For Study Protocol Design

• Principal Investigator Selection

• IRB Approvals

• Beta Testing, Pilot Studies & FDA Required Studies

• Clinical Trial Design, Organization, Execution & Monitoring

• Qualitative & Quantitative Analysis Of Study Results

• Clinical Study Manuscript Preparation & Presentation To Peer Review Journals For Publication

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REGULATORY SERVICES

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• FDA Submissions – 510(k), PMA, IDE

• OTC Product Studies For Self Selection, Usability, Hazards & Precautions

• Domestic & International Device Licensing

• Engineering Services Evaluation As Required For Submissions

• Prototype Design & Development

• Compliance Functions, Yearly Filings & Registrations

• Import & Export Guidance

• Statistical Data Services

• GUDID Services

PRODUCT DESIGN

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• Step By Step Assistance From Patent To Prototype To Market

• Collaboration With Our Experienced Attorneys For Design, Provisional, And Utility Patents

• Knowledge Of Current FDA Regulations And How They Can Help Your Design

• Assistance In Bringing Your Product To Market Sooner & More Efficiently

• Guidance On Potential Product Improvements Based On User Feedback

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FOREIGN AGENT SERVICES

• Domestic Agent Services For Foreign Businesses

• Assistance To Foreign Companies Seeking US Business Opportunities

• Direct Communication With The FDA To Bring Your Product Or Service To The USA

WE ARE HERE TO HELP YOU ACHIEVE YOUR GOALS.

OUR VISION

Regardless of where you are in the process of bringing your product to market, our experts are here to help.  We are clinical trial and regulatory specialists with the knowledge and skills to guide you through every step of the FDA clearance process. Because we believe that each project is unique, we understand the importance of a hands-on personalized approach.  By accepting your project, we are committing to provide your business with both personal accountability and the highest standard of professional service. We are unlike other clinical and regulatory specialists because we are passionate about the success of your business; our vision means bringing your company's vision to life. By employing a team of nurses, designers, statisticians, physicians, photographers, and engineers, we ensure a comprehensive approach with quality results. Here at NST, we know there are many methods that lead to failure, but the possibilities for achieving success are endless. It is this philosophy that steers our business model.

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