Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September.

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.

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.

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."

List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report