End-to-end
Regulatory Services

Fit-for-Purpose, Cost-effective Solutions for small, mid-sized,
and large Pharma companies

Our Regulatory Services

Regulatory Submissions Management

Gain complete oversight of your product life cycle with quality and compliance

Labeling and Artwork Management

Global & local label management, and artwork management

Regulatory Information and Data Management

Leverage our strategic path to RIM excellence

Regulatory Compliance Management

Identify quality issues and ensure patient safety

Regulatory Resourcing

Access our best talent as per your business requirements

Small and Mid-size Pharma

We provide innovative & cost-effective operational quality services to tackle Small and Mid-size Pharma Industry challenges:

  • Global Regulatory Operations
    • Publishing Management
    • Product Life Cycle Management
    • Archival Management
    • Labeling & Artworks
  • Data Management
  • Regulatory Technology and Implementation
  • Regulatory Strategy and Consulting
  • Regulatory Quality Support
  • Regulatory Intelligence
  • Interaction with Regulatory Health Authorities
  • US Agent Support
  • Regulatory Resourcing – Offshore and Onshore
Process Harmonization & Standardization
Process Harmonization & Standardization
Regulatory Services for Compliance & Faster Approvals
Regulatory Services for Compliance & Faster Approvals
End to End Regulatory Strategy
End to End Regulatory Strategy
Lack of Resources & Technology
Lack of Resources & Technology
Timely Deliverables, Scale up Support
Timely Deliverables, Scale up Support
Cost effciency through Operational Optimization (Unit Price Model)
Cost effciency through Operational Optimization (Unit Price Model)
Quality Consistency
Quality Consistency
Regulatory Resourcing
Regulatory Resourcing

Large Pharma

We provide Innovative & cost effective operational quality services to tackle Large Pharma Industry challenges:

  • Global Regulatory Operations
    • Publishing Management
    • Product Life Cycle Management
    • Archival Management
    • Labeling & Artworks
    • Data Management
  • Regulatory Resourcing – Offshore and Onshore
  • Regulatory Technology Implementation
  • Regulatory Intelligence
  • Governance Model

Our Regulatory Value Approach

Consulting

Consulting

Services

Services

Technology

Technology

Nets

Nets

We provide Fit-for-Purpose, Cost-effective Solutions for small, mid-sized, and large Pharma companies. We know your needs as experts with 20+ years of experience to provide tailored solutions. Since 2001, our proprietary networks have brought together 60+ leaders in Regulatory Affairs to network and share ideas on how to tackle 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.

0
eCTD
Submissions
0
NeES
Submissions
0
Paper
Submissions
0
Regulatory
Professionals
0
Years of
Average Experience
0
Customers
0
Technologies
0
Health Authorities

Our End-to-End Regulatory Services helps you to submit First-Time-Right Regulatory Submissions

  • With over 20 years experience, we have successfully delivered 170,000+ Regulatory Submissions across the globe for Pharma & Medical Devices companies.
  • 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.
  • Navitas Life Sciences provides services to small, mid and large size based pharma organizations.
  • We can provide tailor made outcomes based pricing engagement models