A U.S. based life sciences company is the 100th company that will utilize pharmaREADY to publish and submit dossiers on pharmaceutical products to regulatory agencies throughout the world.

The client is engaged in the formulation and commercialization of specialty pharmaceutical products and controlled-release, orally administered, branded and generic drugs with a rich portfolio of intellectual property. The company started with generics and specialty pharmaceuticals and will soon expand globally while also creating medical devices and diagnostics. Biotechnology products have since been added to their portfolio with launches in both the United States and Europe.

The company chose pharmaREADY based on a number of benefits, but responsiveness was a major deciding factor. “When I contacted Navitas, their quick responsiveness reassured us that we could trust pharmaREADY with critical regulatory filings, as they built confidence in their ability to help us,” said the company vice president for regulatory affairs. “We chose the cloud version of pharmaREADY because our IT department is small and we didn’t want to have to invest in purchasing and maintaining a server. And a hosted solution also allows our people to easily access the system remotely.”

The main benefit of pharmaREADY is that it will be up and running quickly, within seven days. Navitas also offers 40 hours of training and 24/7 technical support. Included as part of the installation and support process, Navitas walks all clients through the submission process, a test submission, and then supported with expert staff throughout the entirety of their first submission.

“Choosing an electronic common technical document package is not a decision you make lightly, but pharmaREADY was the most reasonably priced package that we considered,” said the executive. “While price is important, the capability of the software and the training and knowledge that we will gain from collaborating with Navitas for our submissions is what made us choose pharmaREADY,” said the executive.

pharmaREADY was launched in 2003, created by a team of regulatory and technical professionals who had years of experience working with pharmaceutical and biotech companies as well as contract research organizations. Life science clients based in the United States and Canada, Europe, Asia Pacific and the Middle East utilize pharmaREADY to author, publish, and submit regulatory filings for all major regional regulatory bodies, in either paper or specified electronic formats.