Regulatory
Affairs

End-to-End regulatory services that ensure proactive compliance and drive operational efficiency
Strategic Partnerships to optimize your Regulatory Processes, drive First-Time-Right Submissions, and enable Life Cycle Management

With today’s ever evolving regulatory environment placing increased emphasis on Patient Safety, we successfully partner with our clients to navigate the landscape and ensure Patient Safety. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices. Learn more about our End-to-End Regulatory Services.

Navitas Life Sciences is your experienced partner for your End-to-End regulatory needs

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Navitas Life Sciences offers the tailored End-to-End Regulatory Services from Research to Commercialization for both Innovator & Generics sponsors

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Our Regulatory Services

Regulatory Strategy

Customized solutions, grounded in industry best-practices, supported by our industry networks

Regulatory Process Consulting

Optimize your regulatory processes, minimize risk and ensure compliance

End-to-End Regulatory Services

Comprehensive services to deliver first-time-right submissions

Regulatory Technology

Solutions for all your needs from planning, to submissions, to content management to quality & compliance

Regulatory Networks

discuss trends, develop insights, & build future solutions

Life sciences companies must achieve and maintain compliance

  • Implement holistic benefit-risk management
  • Drive First-Time-Right Submissions in a cost-constrained environment
  • Manage enterprise-wide product data
  • Maximize speed-to-market and approval success rates
  • Ensure harmonized operations
  • Enhance commercial success through optimal product life cycle management
  • Achieve Regulatory Information Management Process Flow excellence
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Our Regulatory Strategy team, with over 20 years of experience, can help you navigate the regulatory landscape as trusted advisors, providing strategic oversight, industry benchmarks, and insights.
We have vast experience in providing Regulatory Process Consulting for all varieties of submissions globally.
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Our End-to-End Regulatory Services helps you to submit First-Time-Right Regulatory Submissions. With over 20 years of experience, we have successfully delivered 170,000+ Regulatory Submissions across the globe for Pharma & Medical Devices companies.
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We specialize in Regulatory Technology, providing application infrastructure for end-to-end regulatory, content management, quality, track & trace, serialization, and business intelligence
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Since 2001, our proprietary industry networks have brought together 60+ leaders in Regulatory Affairs to network and share ideas on tackling the latest strategic challenges. Our networks give us benchmark insights into the latest industry trends and enable us to future-proof your strategy and operations.

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Flexible pricing models. We offer unit-based pricing, which is our unique outcome-based engagement structure where clients pay in line with the submission workload. Our lean, reliable, and cost-effective partnership model is designed to ensure a smooth approval process while optimizing costs, accelerating time-to-market, and reducing risk of non-compliance/de-licensing.