OUR VALUES

Inspire our customers through our pace of innovation

Foster Trust in our work through relentless commitment to our customers

Demonstrate Humility by serving our customers with the highest quality product and services

OUR MISSION

We are passionate about Technology. Our Mission is to partner with Sponsors and bring medicine to patients faster.

We want to continue to innovate and build applications that will streamline end to end drug development processes.

Our initial set of applications released is in the Regulatory space.

OUR SKILLS

Cloud Platform Development
100
Life Science Experience
100
Regulatory Publishing Experience
100
Consulting
100

DnXT Platform

Are you ready to experience innovation at its finest? Discover our cutting-edge SaaS platform designed for Regulatory, powered by the latest technology and hosted securely on the robust Azure platform. Whether you’re head of Regulatory, an IT business parter, or simply someone who appreciates top-tier performance, our web app is designed to exceed your expectations.

Unparalleled Performance

Our Java-based solution ensures lightning-fast response times and seamless user experiences. Say goodbye to sluggishness and hello to efficiency!

Azure Hosting

Our platform is powered by Microsoft Azure for its world-class reliability and security. Your data is in safe hands with our state-of-the-art infrastructure.

Sleek User Interface

Our application boasts a modern design that enhances usability and captivates your audience.

Advanced Features

Get ready for a plethora of advanced features that enrich your productivity. Our pace of innovation exceeds all of our competition.

Scalability:

Whether you’re expecting a handful of users or your entire origination, our platform effortlessly scales to accommodate your needs, ensuring optimal performance at all times.

Seamless Integration

No cost integrations. Our system integrates with existing systems and processes, making adoption smooth and hassle-free. All DMS systems supported.

DnXT RIM Suite

We believe Regulatory function to be a strategic capability of drug development as opposed to an administrative overhead. Our ambition is to shorten drug approval time from last clinical trial to first submission in under 4 weeks.

Our goal is to allow our customers to own a Regulatory SaaS system that  seamlessly integrates with the marketplace (CROs, Affiliates). Flexibility to outsource parts of the regulatory operation by having total control of the end to end process.  We have developed a platform that is intuitive, fast and just works.

Applications Released

DnXT Planner

SWIPE NAV

Compellingly reinvent Planning of your submission
Ability to view calendars
Ability to plan on Authoring, Reviewing , QC time
Toggle view between Project Plan, eCTD Tree, Tile list
Timeline view with Milestones
Automation with notification
Collaborative Authoring

DnXT Publisher

SWIPE NAV

Compellingly reinvent Planning of your submission
Ability to view calendars
Ability to plan on Authoring, Reviewing , QC time
Toggle view between Project Plan, eCTD Tree, Tile list
Timeline view with Milestones
Automation with notification
Collaborative Authoring

DnxT Validator

CLEAN CODE

Compellingly reinvent 24/365 schemas rather than enterprise systems enthusiastically

DnXT Reviewer

One Stop Reviewing Solution

Impressive Dashboard: Monitor Submission and Application Status
Streamlined Workflow with Email Notifications: Effectively oversee your review process with confidence; manage comments and link repair tasks effortlessly with just a click.

DnxT Registration

CLEAN CODE

Compellingly reinvent 24/365 schemas rather than enterprise systems enthusiastically

OUR SERVICES

DNXT Services has been recognized as a top regulatory services company and specializes in simplifying the complex process of regulatory submission management. We work closely with our clients to handle various aspects of the process, allowing clients to concentrate on their scientific innovations. The services provided by DNXT include Technical Implementation, Validation, Migration, Publishing Services and Regulatory Strategy

Regulatory Submission Strategy

We work closely with your team to develop a tailored strategy for your regulatory submissions. Our experts analyze your product and market to create a roadmap that optimizes timelines, resources, and compliance.

Content Planning and Management:

Our team assists in developing and managing a robust content plan for your submissions. We ensure that the right content is prepared, reviewed, and organized according to agency requirements and guidelines.

Compilation and Quality Assurance:

We manage the compilation process meticulously, addressing any issues from identification through resolution. Our quality assurance measures and version control tracking ensure accuracy and compliance. Our experts analyze and publish submission components, interpreting guidance requirements for each. We apply practical knowledge of validation criteria and utilize advanced technologies to verify compliance and produce a polished final output.

Electronic Submissions Gateway (ESG)

We handle the technical aspects of obtaining signing certificates and submitting premarket and postmarket regulatory information to the FDA. Our team manages gateway receipts for a seamless submission process.

Deadline Management and Adaptation

We keep track of agency deadlines and proactively respond to challenges, presenting you with various options to navigate complex situations effectively.We believe in close partnership and transparent communication. Our team works collaboratively with your organization, keeping you informed at every step of the process.

FREE SUPPORT

Our commitment to excellence has been acknowledged by industry recognition, having been awarded as a top regulatory services company.

Publishing Experience

0
SUBMISSIONS IMPORTED
0
SUBMISSIONS PUBLISHED
0
REGION SUPPORTED
0
CONSULTING HOURS

OUR CLIENTS FEEDBACK

  • William Evans

    We have been using DnXT Services to work on 2 NDAs. Their Regulatory knowledge is outstanding. They are reliable and have been an amazing Partner.

    William EvansHead of Regulatory
  • Head of RIM
    We use DnXT Reviewer for our review and Archvial proccesses. Great Product and Great Services.
    Head of RIMLuyePharma

We would love to know you

To learn more and explore how our regulatory publishing and strategy services can benefit your organization, please contact us for a free consultation. We look forward to helping you navigate the regulatory landscape with confidence and efficiency.