Programs
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for Leaders, Learners, and Innovators
Access for every professional wherever your Organization, whatever your mission.
Trusted by Leading Organizations
Partnering with industry leaders and innovators in NYC and beyond
FDA Agency Assistance
Who It's For:
Government professionals working at the FDA or other regulatory agencies (.gov accounts).
How it works:
We provide our dashboard and services to those affiliated with the agency for the purpose of conferences or other presentations. Our advanced data visualization tools significantly enhance regulatory presentations with precise, real-time compliance insights and analytics.
Our Thesis:
This program aims to foster collaboration between industry and regulatory bodies, promoting a shared understanding of compliance challenges and solutions.
One-week enrollment opportunity - You must use your HHS or FDA email
Academic Support
Who It's For:
Students and .edu accounts working on medical devices or pharmaceutical products.
How it works:
Sign up with a .edu account and book a demo noting your project.
Our Thesis:
Students and academics should be able to have easy and instant learning of potent regulatory pathways, hiccups, and notes. GKS empowers that.
Must use a valid .edu email address
Support for Small Firms and Independent Consultants
Who It's For:
Small businesses and startup consultancies (1-5 FTE) can access GKS tools through our success-based program designed specifically for emerging firms.
How it works:
Use our platform for your client engagements to save time and add citable credibility to your work. Pricing and support are customized for small teams, with options for objective-based partnerships that help you win new client work.
Our Thesis:
Bringing instant value to the firms that need risk free tooling to get started.
Designed for emerging firms
483 Response Support
Who It's For:
Firms that have recently received a 483 observation.
How it works:
KeyPedia automatically writes and assists with FDA Form 483 responses.
Our Thesis:
This is a special program for companies that have received FDA Form 483 observations, we work best in preventing this situation. Our solution is truly a preventative approach to regulatory compliance.
Warning Letter Response Support
Who It's For:
We offer our data dashboard solution at no cost to companies that have received warning letters or FDA Form 483s within their 2-week response window.
How it works:
We want to support companies with the best possible warning letter response that they can provide. Our dashboard can work well within your team quickly and effectively to get to the answers you need for your response.
Our Thesis:
This is a special program for companies that have received warning letters, we work best in preventing this situation. Our solution is truly a preventative approach to regulatory compliance.
Benchmarking Meetings
Who It's For:
GKS will grant a complimentary consultation to firms looking to revitalize their internal tooling.
How it works:
To help facilities directly benefit from our system, risk-free, this program will be conducted by our expert panel.
Our Thesis:
Firms have benefited in avoiding FDA Form 483s by utilizing our system. As part of our Warning Letter response support, we recognize many teams prefer internal, already understood tools; however, these tools don't serve a broad enough purpose.
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