Regulatory:

Stay compliant and competitive

Life sciences organizations must overcome significant challenges in managing regulatory requirements through the drug lifecycle. Managing the differences in requirements across health authorities, frequent changes to submission requirements, fragmented data sets across multiple stakeholders/systems, and rising overheads due to flux in submissions workload are integral to a successful process.

In order to remain compliant and competitive, life sciences companies must implement holistic benefit-risk management, drive proactive compliance in a cost-constrained environment, manage enterprise-wide product data, maximize speed-to-market and approval success rates, ensure harmonized operations, and enhance commercial success through optimal product life cycle management.

Navitas Life Sciences Is Here to Help

As experts with more than 70,000 regulatory submissions under our belt, Navitas Life Sciences has the capabilities to support the regulatory end-to-end lifecycle management across the entire value chain of drug and device regulatory environment. 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.

With insights from more than 5 technologies and more than 10 health authorities, 60 associates, 30 executives, and 5 internal consultants, we drive better outcomes for our clients, as proven by our experience handling 17,000 paper, 40,000 eCTD, and 10,000 NeeS submissions. We also offer two regulatory industry networks, rimnet and labelnet, to help Regulatory Information Management (RIM) professionals develop best practices and leading edge solutions for RIM and to help labelling professionals focused on the full lifecycle of labelling, respectively.

Our Regulatory offerings include:

  • Regulatory consulting
  • Global submission management and report publishing
  • CCDS, labeling, and artwork
  • Medical writing
  • License maintenance for marketed products
  • Application management services
  • Technology
    • Technology assessment, sourcing, implementation, and hosting
    • RA system implementation
    • IDMPReady®
    • RIM solutions
  • Industry networks:
    • rimnet (logo) labelnet (logo)

A web-based electronic Document Management and eSubmission Solution

PharmaReady

Our Approach

The unit price

The way we operate

The way we engage with our clients

Latest News

05
Jul2017

From fifteen to future – Navitas Networks 15 year anniversary

Navitas industry networks recently celebrated its milestone 15th year of delivering insights and creating...

09
Jun2017

Life Sciences expert Navitas augments end-to-end capabilities

Navitas, a technology-led Life Sciences services provider across Clinical, Regulatory and Safety, announced that...