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Navitas introduces new regulatory process outsourcing model
PRINCETON, N.J.—The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years, driven by greater and more complex global regulatory requirements. At the same time, there are increasing cost pressures on regulatory functions. Companies are being forced to adopt innovative technology solutions and outsourcing models as potential ways to meet these cost, capability and capacity challenges.
Shalabh Kumar, global head of services at Navitas, explains that the growing requirement to do more with less has forced companies into outsourcing, with larger pharmas leading the parade.
Regulatory process outsourcing in particular is an emerging solution for global companies. To address the new regulatory landscape, Navitas has integrated industry insights from its nets in the regulatory domain and its technology capabilities and partnerships, into an innovative suite of process outsourcing services for life-sciences companies under the banner “Process Outsourcing Enhanced by Technology.”
The suite of Navitas regulatory services includes submissions and report publishing, license maintenance for marketed products, labeling and artwork services, regulatory information management and regulatory strategy and support. Navitas also provides subject matter expertise in evolving electronic submissions standards and health authority-specific guidelines and processes. At the core of these services is the company’s state-of-the- art Global Delivery Center in Chennai, India, and an emerging delivery center in Bogota, Columbia, providing scale and cost efficiency.
As an innovator in the regulatory process outsourcing industry, Navitas recently celebrated three years of a global regulatory submissions partnership with one of the world’s largest pharmaceutical companies. The partnership program compiles, formats, publishes and distributes regulatory compliant submissions to drug approval agencies throughout the world. Navitas functions as an extension of the company’s internal Regulatory Operations group and handles more than a third of the company’s annual submissions.
“Publishing is our most mature and best-established function,” Kumar states. “Labeling is also very important where we have a long industry record, as well as safety monitoring,” which, he notes, “never goes away.”
Navitas also provides the proprietary software PharmaReady, a web-based electronic document management and e-submission software with ease of installation, ease of use, regulatory compliance and affordability as its primary features, typically used by Naviras’ smaller clients (the company uses larger clients’ own software in many cases).
PharmaReady is specifically designed for both emerging and large life-science organizations where ease of installation, ease of use, regulatory compliance and affordability are the primary business drivers. The PharmaReady solution suite is designed for management of standard operating procedures, work instructions, training records, eCTD submission documents and all other electronic documents, and is in full compliance with global regulatory requirements.
Kumar adds that “The challenges faced by our clients in the pharmaceutical industry in light of increasing and more complex regulatory requirements can only be addressed by innovative solutions. In integrating our process outsourcing and technology capabilities, we have created a suite of services which are unique in this sector.”
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 advice, solutions and outsourcing services in clinical, regulatory, safety and content management,” Kumar summarizes.
“We are proud that our legacy businesses have served the sector for some 15 years and have allowed us to work with 100 of the top life-science companies. Our team has now grown to over 500 staff.”