BRING YOUR PRODUCT TO MARKET

SPECIALIZING IN INNOVATIVE CLINICAL AND REGULATORY SOLUTIONS FOR COMPANIES NAVIGATING THE FDA

WHAT
WE DO

CLINICAL TRIAL SERVICES

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 and Presentation To Peer Review Journals for Publication

REGULATORY SERVICES

FDA Submissions – 510(k), PMA, IDE
OTC Product Studies For Self Selection, Usability & Hazards and Precautions
Domestic & International Device Licensing
Engineering Services Evaluation as Required for Submissions
Prototype Design & Development
Compliance Functions, Yearly Filings and Registrations
Import and Export Guidance
Statistical Data Services
GUDID Services

PRODUCT DESIGN

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

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.