Labeling revisions across 10+ CMOs and 32 products

Feeling stuck with a solution that couldn’t keep up with a growing workload

After Azurity Pharmaceuticals expanded its portfolio of products, the Regulatory Affairs team needed to manage a higher volume of proofreading tasks.

Azurity Pharmaceuticals is a specialty pharmaceutical company headquartered in Boston, Massachusetts. It focuses on innovative medications for underserved patients.

Raquel Terry, Director of Regulatory Affairs at Azurity Pharmaceuticals, leads a team of four. They are responsible for labeling and promotional review.

After expanding from 6 to 32 products, the team realized that the automated proofreading tool they had before TVT — GlobalVision — couldn’t keep up: 

• only one person could access the cloud solution
• the reports were hard to interpret and explain to the CMOs, and 
• the vendor’s technical support fell short.

Instead of speeding things up, it became another bottleneck.

Finding a tool that can speed up reviews

Contracting with 10 to 15 CMOs across the world means the team needs to review updated labels quickly to prevent delays.

The RA team members wanted to be able to review labeling and promo materials quickly and independently — and have an easy way to send requests for additional updates to CMOs.

Following the company due diligence process, they tested different automated proofreading solutions, including TVT.

Ultimately, Azurity decided that TVT was the right solution for their needs.

Staying on top of labeling reviews with a team of four

The RA team can now confidently manage a high-volume workload.

Team members are very happy with TVT. 4 days a week, the team jumps on a 15-minute call to discuss upcoming review tasks and distribute them.

Then, they complete content verification tasks independently from each other.

To speed up revisions with CMOs, they rely on TVT reports: “We work with around 10 to 15 contract manufacturing organizations and for this TVT is invaluable. We can immediately see what changes the CMOs have made, and whether anything else has changed that shouldn’t.”