The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years

September 10, Princeton, New Jersey:Navitas Introduces Innovative Regulatory Process Outsourcing Model

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.

Regulatory process outsourcing 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 a unique and innovative suite of process outsourcing services for Life Science companies under the banner ‘Process Outsourcing enhanced by Technology’.

The suite of Navitas Regulatory Services includes: Submissions & Report Publishing, License Maintenance for marketed products, Labeling & Artwork Services, Regulatory Information Management and Regulatory Strategy and Support. Navitas also provides invaluable subject matter expertise in evolving electronic submissions standards and health authority specific guidelines and processes. At the core of these services is our 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.

Navitas also provides the proprietary software pharmaReady®. pharmaReady is a web-based electronic Document Management and eSubmission software with ease of installation, ease of use, regulatory compliance and affordability as its primary features. Shalabh Kumar, Navitas’ Global head of Services, commented, ‘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.’

About Navitas

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.

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. For more information, visit www.navitas.net

 

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