Navitas Life Sciences named ‘Top 10 Innovator - Pharma and Life Sciences Solution Providers 2022'- Insights to why we are Preferred Innovative Partners

Medhealth Outlook has named Navitas Life Sciences as a Top 10 Innovator – Pharma and Life Sciences Solution Providers 2022.

Navitas Life Sciences is a technology-driven CRO providing end-to-end and point services across Clinical, Regulatory and PV for pharma and biotech companies world wide. Navitas provides outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Over the years, we have supported 550+ clinical trials across 20+ therapeutic areas, 200,000+ regulatory submissions, and 300+ PV consulting engagements. Our proprietary network forums "NETS" have over 120 members from top companies across the globe.

Navitas Life Sciences named as a ‘Top 10 Innovator - Pharma and Life Sciences Solution Providers 2022’ by Medhealth Outlook

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Top 4 Reasons Why we are a Top Innovator CRO

1) OneClinical^® Analytics: Leveraging the Right Technology to Power Efficient Clinical Trials

Productive patient monitoring and effective clinical endpoint detection are some critical challenges for a successful trial. OneClinical^® Analytics provides near real time data during the trial, which can be used to better control such variables during your trial. The use of such intelligent analytics empowers you to take proactive corrective action, resolving critical issues at the onset. This will help in the intelligent deployment of resources which can save your time and your money.

2) Innovative End-to-End Clinical Trial Support

Navitas Life Sciences is a trusted clinical research organization focused on supporting clinical trial needs of small, medium and large life sciences companies globally. We deliver platform-driven end-to-end clinical trials, right from clinical trials operations, medical services, regulatory, pharmacovigilance and clinical data services.

3) Implementing compliance with pharmaREADY^®

Imagine a system that evolves with the changing regulatory landscape, creates improved time and cost efficiency, embeds compliance with user-friendly and flexible workflows, and upholds the spirit and not just the letter of regulatory compliance. pharmaREADY^® is that system, and it has been built exclusively to support your regulatory submission needs.

Benefits of pharmaREADY^®

• Seamless Integration: Integrates all modules (DMS, eCTD, SPL, and TRMS)
• Time saved: Submissions prepared in 40% less time
• Cost Effective: Lowest Total Cost compared with similar systems
• User Friendly: Intuitive and easy to use
• Simple and Fast: Set up and run within 3-4 weeks
• Support: End user training and 24/7 post-sales application support
• Always ahead: Regular updates with regulatory guidelines and technology innovations
• Compliant: 21 CFR Part 11, Annex 11, cGMP and HIPAA compliant, and inspection ready
• Data Migration: Simple data migration with no user intervention required
• Backward Compatibility: Old methods can be used for imported legacy submissions

4) Adding Value to TrackWise^® Implementations

TrackWise^® Digital, a solution from Sparta Systems, a Honeywell Company is the first 100% cloud-offered electronic Quality Management System (eQMS) available in the market, and it is 21 CFR Part 11 compliant (Including 820, 821, 210, and 211). It is offered on the state-of-the-art Salesforce.com platform and delivered as an online web application, fully mobile with offline capabilities.

How traceREADY^® can help with Mandatory QR Code for API Medicine

The Central government of India has mandated that the label of all active pharmaceutical ingredients (APIs) manufactured or imported in India should contain a Quick Response (QR) code on each level of packaging. This amendment rule is being put forward to allow effective tracking and tracing of the ingredients of the drugs, and to prevent spurious drugs from entering the market.

With the impending requirement timeline, Navitas Life Sciences offers traceREADY^® Label Printing Module, a robust and scaleable solution, which can work hand in hand with your existing business processes in sufficing requirements as stated in GSR20(E). The validated hosted/on-premise solution can accommodate your Business specific requirement and is able to handle further upgrades in terms of regulatory requirements.

Working as an additional layer complementing established best practices, we offer uncompromising quality with practical implementation plans, not exceeding 4 weeks, to ensure the load on the business is not too heavy.

Adding value to government’s mandated QR code on all APIs

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Santosh Narayanan BT,

Senior Business Analyst Consulting,
Navitas Life Sciences

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