Regulatory technology

For one source of truth to deliver first-time-right submissions

Planning, tracking & control
Regulatory Information Data Management System
Labeling Information Management System
Content development & repository
Document Management System
(Dossier, SOPs, Training Records, QA Documents and other Regulatory Documents)
Quality & Compliance Systems
Track & Trace, Serialization
Quality Management System
Training Records Management System
Submissions Management
IDMP Management Systems
Structured Product Labeling
Electronic & Paper Publishing

Well established technology partner for the life sciences industry

Navitas life sciences specializes in providing application infrastructure for regulatory, content management, quality, track & trace, serialization and business intelligence. Global standards are adopted & institutionalized across all services covering ISO, GAMP5, GxP and 21-CFR Part 11 compliance needs. These alignments ensure that the product or services offered are in line with the statutory requirements of all regulatory bodies. Navitas life sciences experts provide you 24/7 support from training to implementation and will walk you through your first submissions.

Our regulatory technologies are :

  • Intuitively operated platforms
  • The most economical for regulatory submissions in the industry and enable faster product approvals and commercialization
  • Fully integrated, compliant, web-based platforms to create and manage your global regulatory submissions either on premise or cloud based.

Our regulatory technologies empower core advantages

Standardize

Standardize

achieve global and local regulatory compliance
Optimize

Optimize

provide streamlined holistic processes

Align

Align

global cross-functional alignment with internal & external business roles
Accelerate

Accelerate

shortening the overall timeline for submission
Save cost

Save cost

cloud based or on premise economical solutions for small, medium & large pharma