The Challenge of proofreading manually
Raquel Terry leads a team of four people who are responsible for labeling and promotional review. When she joined Azurity Pharmaceuticals as Director of Regulatory Affairs in 2020 the company had six products. Azurity Pharmaceuticals adapts products to meet the needs of underserved patients. Many of these products have been on the market for many years prior to being adapted and have a great deal of accompanying data. Due to a gradual expansion of its product portfolio and through corporate acquisition, Azurity Pharmaceuticals currently has over 32 products on the market.
Day-to-day responsibilities of the team involve creating and updating all labeling and associated information, such as prescribing information (PI) for healthcare professionals to ensure the correct dosage and use of the medications, important safety information (ISI) which summarizes product benefits and risks, primary packaging (i.e. packaging that has direct contact with the medication) and secondary packaging. These components are routinely updated based on numerous factors, which may include vendor changes and regulatory-related changes as new information becomes available.
Label creation and updates are performed as part of a complex, layered relationship. The labeling team works closely with internal stakeholders and contract manufacturing organizations (CMOs), as Azurity products are manufactured around the world. In many cases, the CMOs contract with other CMOs. In addition, the labeling team partners with the regulatory product lead who monitors and manages all CMC (Chemistry, Manufacturing, and Controls) product changes.
An increase in the number of products after the acquisition presented new challenges for the labeling team, which had been proofreading manually. “This worked because we made it work,” Raquel explains. “But it was slow, time-consuming, and cumbersome.”
The team felt it had to find a more efficient solution.
Choosing TVT as a proofreading software
“The company we acquired had been using proofreading software from one particular provider,” Raquel explains, “but we found this complicated. It was installed on a remote desktop accessible to only one person, and the reports were complex and took a long time to go through.” Furthermore, the team was unimpressed by the level of technical support. In all, this led to bottlenecks and even more pressure on the team.
One member of the labeling team had previously worked for Sanofi, a leader in the pharmaceutical industry that uses TVT, the Text Verification Tool from Schlafender Hase. Nevertheless, Azurity Pharmaceuticals decided to road-test a range of other proofreading software. The results were dissatisfying: too complex, too much training required, and lacking in user-friendliness.
Having a member on the team who had used TVT and spoke well of it made selection easier. Internal steps for due diligence and purchasing were set in motion and after consulting with Schlafender Hase, the company road-tested TVT with a trial demo before full implementation. “The Schlafender Hase team provided us with a smooth experience and they were there at each step guiding us and answering our questions, which was a huge plus.” Adds Raquel.
The entire team at Azurity is highly satisfied with the results. “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,” Raquel explains. “We used to spend time meeting together with the Regulatory Product Lead going through labeling sentence for sentence on an overhead screen. This could take us up to 8 hours for one PI. Not anymore. We’ve gained tremendous efficiencies with TVT, and the time savings are astronomical. We can quickly run and review a report, which is easy to understand, and provide this as a supporting document to substantiate the work of the team.”
“Using TVT is easy, providing a clean and simple way to make updates, and it verifies for the end customer that nothing else has changed. That provides a level of customer service that without TVT we simply could not provide before.”
Furthermore, the three licenses have been highly cost-effective and compatible with the budget the company allocated to a proofreading solution. “TVT gets the job done, quickly and efficiently. And we’re very pleased with the service,” Raquel adds.
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company headquartered in Boston, Massachusetts. It focuses on innovative medications for underserved patients, with products spanning the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets. A key element of its business approach is the adaptation of medications for patients with unmet needs. This includes the reformulation of longstanding, trusted products to make them suitable for geriatric and pediatric patients.