Customer

Quantum Regulatory Solutions

Location

Kalamazoo, MI, USA

Industries

Healthcare

Offerings

Consulting & Engineering Services

Customer Stories | June 3, 2025

Quantum brings new drugs to market faster

Bringing new drugs to market quickly can significantly impact the lives of those who rely on them and, in some cases, can even be a matter of life and death.

Yet, pharmaceutical companies face a long, complex, and highly regulated process to ensure that safety and efficacy are established before reaching the patients who depend on these breakthroughs. It’s a process that can take, on average, more than 10 years and cost billions of dollars. 

The U.S. Food & Drug Administration (FDA) breaks down the drug development process into five steps, including clinical research to assess how a drug interacts with the human body and its potential to deliver the intended benefits. 

Helping to speed up the process

Human testing can only begin after a pharmaceutical company submits an Investigational New Drug (IND) application, detailing the drug’s profile—such as toxicology reports, manufacturing procedures and clinical trial protocols—using FDA-approved templates, all within carefully coordinated timelines.

Failure to submit the IND application correctly and on time can result in rejection, delays and costly resubmissions, ultimately postponing the availability of potentially life-changing treatments for patients in need.

Enter Quantum Regulatory Solutions, a boutique consulting firm that specializes in helping pharmaceutical and biotech companies prepare and submit regulatory applications to the FDA for clinical trial applications and marketing approvals. Quantum uses DXC’s ToolBox Pharma Edition*, a regulatory information management (RIM) application that streamlines production of FDA-compliant documents.

*DXC Toolbox Pharma’s latest version [v6.5] uses DXC’s FirstPoint RIM.AI—a cloud-native AI Automation framework—to accelerate regulatory filings by up to 60%.


Having seen the success of DXC’s solution at her previous company, Jennifer Harmon, Associate Director of Regulatory Publishing at Quantum, was eager to implement it at Quantum as well. 

“This solution makes such a difference in how quickly we can process documents for all types of regulatory applications,” Harmon says. “DXC ToolBox reduces our processing time by 50%.”

Not only has Quantum's capacity to take on new business increased as a result, but by successfully processing clients' regulatory applications it helps these companies keep on track with regulatory requirements as they run their clinical trials and beyond.

Ultimately, this helps Quantum’s pharmaceutical customers accelerate the journey of new drugs to market, delivering life-changing treatments faster to patients in need.

 

The big picture

Speed, precision and regulatory compliance are critical to bringing new life-changing treatments to people around the world. DXC helps organizations like Quantum Regulatory Solutions accelerate the production of FDA-compliant regulatory documents, in this case reducing processing time by up to 50%.

And this is just one example. With deep expertise in life sciences and cloud-native AI solutions, DXC is helping pharmaceutical companies create faster, more efficient paths to drug approvals. This helps drive positive business outcomes while making a meaningful impact on the health of millions of people.

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