Technology-Assisted SaMD & Healthcare Solutions.

Launch

Launch with Confidence.

01. Strategy & Design

Rooted in advanced data science and machine learning, our team offers a wide range of strategic expertise, from market analysis and consumer insights to feature planning and usability engineering. Our goal is to understand how your customers think, feel, and talk. We connect products to people as efficiently as possible.

02. Development & Validation

We take a comprehensive approach to cloud-based infrastructure design and development, including agile development of cloud-based software and native apps. We prioritize cybersecurity and data privacy by rigorously testing throughout the product development lifecycle.

03. Recruiting & Launch

Recruiting for clinical trials can be an unforeseen hurdle on the way to regulatory approval. We specialize in managing digital recruiting to minimize associated time and cost. The commercial launch marks the culmination of all the foundational work. With years of experience uniquely positioning therapeutics and pharmaceuticals, we provide a seamless transition to commercialization.

Platform

CodeScripts

CodeScripts is the first SaMD platform to increase accessibility to prescription medications through technology assisted qualification. Finally, consumers can access critical medications that were once only available by prescription.

Pharmaceutical companies can safely market their prescription medications as OTC through the FDA's ACNU guidance.

ACNU

Accelerating Consumer Access with ACNU.

In June of 2022, the FDA released a proposed rule that intends to expand the availability of nonprescription drugs to include those with an additional condition for use (ACNU). These ACNUs are designed to ensure appropriate self-selection, actual use, or both, can be done by consumers without the supervision of a healthcare provider.

For over 7 years, we have been a part of programs pursuing this ACNU designation and our first program has most recently completed its Actual Use Trial.

This ACNU designation has allowed our clients to breathe new life into mature brands, reinvigorate programs where the Rx-to-OTC switch could not be done with the label alone, and tackle public health issues on an unprecedented scale. Let us help your team achieve similar success.

Core Solutions

Core Solutions.

Insights.

Customized Data Science
Behavior Analysis
Competitive Analysis
Intelligence Platform

Regulatory.

FDA Compliant Pathway
Study Protocol Support
Design History File
Trial Recruitment

SaMD.

Design & Development
ACNU Specialists
Human Factors Prototyping
ML/AI Modeling

Launch.

Strategy & Optimization
eCommerce Execution
Digital Advertising
Commercial Support