PROCESS Development

Convert breakthrough formulations into scalable manufacturing processes with pharmaceutical engineering expertise.

Years
60 +
development-to-commercial scaling
0 x
successful FDA inspections
0

Bridge the Lab-to-Market Gap Successfully

ARx applies 60+ years of adhesive development and coating expertise to optimize every process development stage, ensuring a seamless transition from formulation to full-scale manufacturing. Our Quality by Design (QbD) approach establishes critical process parameters early, reducing variability and improving yield efficiency.

We employ proprietary in-silico modeling to predict polymer-API interactions, refine drying and curing conditions, and enhance adhesion properties before production begins. This data-driven approach accelerates development timelines, minimizes material waste, and ensures batch-to-batch reproducibility, positioning your product for regulatory approval and commercial success.

 

Benefits


Regulatory Certainty: Nine successful FDA inspections and four “no observation” DEA inspections since 2006.


Supply Chain Protection: Vetted supplier network with comprehensive quality assurance throughout development and commercial processes.


True Partnership: Cross-functional integration through ASQ-certified GMP professionals aligned with your development goals.


Perpetual Advancement: Systematic process refinements based on six decades of film and adhesive polymer science expertise.


Global Market Access: Comprehensive documentation supporting worldwide regulatory filings, backed by thorough monitoring program.


CAPABILITIES

Our process expertise spans from early feasibility through commercial-scale manufacturing, developing robust processes for thin films and transdermal systems.

ARx combines QbD principles with proprietary models to optimize formulations and enhance permeation, ensuring on-time, on-budget results.

Compare Dosage Forms

Interested in how novel drug delivery systems compare to traditional methods?

Explore their unique advantages and identify the best fit for your formulation needs.

Your Partner in Process and Design

At ARx, we bridge the critical gap between laboratory discovery and commercial reality. Our engineering expertise, proven through multiple 505(b)(2) and ANDA program approvals, creates the defined pathway your therapy needs to reach patients faster.