PRINCETON, N.J., July 12, 2016 /PRNewswire/ -- pharmaREADY® is Navitas' intuitive and easy to use, fully integrated, regulatory compliant, web-based suite comprised of modules for eCTD Publishing, Paper Publishing, Document Management, Training Records Management, and Structured Product Labeling. pharmaREADY simplifies the complex process of creating, viewing, and managing submissions – electronic, NeeS, or paper.
A U.S. based Life Sciences company is the latest (and the 100th) company that will utilize pharmaREADY to publish and submit dossiers 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 client's Vice President of Regulatory Affairs 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." Going on to state, "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." Finally, the main benefit of pharmaREADY is that it will be up and running quickly (5-7 days). Navitas offers 40 hours of training and 24/7 technical support as an added bonus. 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 eCTD package is not a decision you make lightly, but pharmaREADY was the most reasonably priced package that we considered. 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."
pharmaREADY was launched in 2003, created by a team of highly skilled regulatory and technical professionals who have years of experience working with pharmaceutical and biotech companies as well as Contract Research Organizations. pharmaREADY is a low cost (lowest total cost of ownership in the industry) cloud or on premise regulatory suite designed specifically for the virtual/small-to-medium sized life science company. 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. For more information, visit www.pharmaready.com
The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting. We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advise, solutions, and services in Clinical, Regulatory, Safety, and Content Management. We are proud that our legacy businesses have served the sector for some 20 years and have allowed us to work with 100 of the top Life Science companies. Our team has now grown to over 400 staff.
We pride ourselves in our role as Expert Navigators. Interpreting market and regulatory change; driving collaboration across companies; seeking the simple solution to the complex problem; investing to enable the changes. Motivated by the success of our clients, we thrive on working together with clients, partners, and each other, across geographies, time zones, and cultures. For more information, visit www.navitas.net
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