INFOSYS LIFE SCIENCES REGULATORY SUBMISSION PLATFORM

A comprehensive, cloud-based solution for the regulatory submissions life cycle

The tedious process of regulatory the hour is thus to optimize regulatory need to keep up with greater scrutiny
submissions often prevent organizations submissions to accelerate time-to-market, by regulators and the dynamism
from realizing the benefits of investments reduce cycle times with regulators, save of compliance. As a result, they are
in research and new markets, making it patients’ lives, and maximize research increasingly feeling the need to
a critical function for biopharmaceutical investments and value. At the same streamline related operations and smartly
organizations to manage. The need of time, biopharmaceutical organizations manage global, submissions’ life cycles.

An end-to-end solution from Infosys

The Infosys Regulatory Submission platform accelerates and streamlines all aspects of regulatory submission — from planning, document
creation, review and approval, tracking and submission. It resolves business challenges by providing:

Best-in-class tools

Seamlessly integrated, end-to-end services The platform is integrated with industry-leading tools that
provide:
The platform offers comprehensive regulatory
submissions capability in a collaborative business
• Centralized content authoring and dossier
management
model. It includes:
• Submission planning • Product Registration management

• Product Registration • Versatile publishing functionalities

• Document management, including approval • eCTD | NeeS assembly, review, and submission
workflows management

• Document publishing and submissions • Reporting in Extended EudraVigilance Medicinal

Product Dictionary (xEVMPD) and Structured Product
• Submissions tracking
Labeling (SPL) formats
• Search, dashboards, reports, and analytics
• An interface with an electronic gateway for
submissions and reporting
 Solution and technology Governance
• Single source of truth, providing a fully • Timely responses to health authority queries
integrated system for all regulatory • Seamless submission to multiple regulatory
submission needs bodies in different regions
• Integrated processes and data with • Reusable artifacts across the enterprise and
standard SOA factory architecture extended organization
• Fully secured solution delivered through • Disclosure of litigation information within an
the cloud acceptable time-frame
• Enhanced visibility
Highlights
Operational
• Proactive adoption of new regulatory
Continuous upgrades
standards
• Standardized, end-to-end, processes for • Platform is compliant across sectors
planning, creation, publishing, and tracking • Responds to continuous assessments and
of submission documents upgrades to regulatory changes
• Collaboration with partners through • Supported by an expanding platform
integrated processes and systems roadmap

Unique selling proposition

The Infosys Regulatory Submission platform has proven its capabilities at a leading pharmaceutical company. Here are some factors that give
it a competitive advantage:
Best-in-class Unique delivery model Capability and expertise
• Designed exclusively for regulatory • Solution and service from the secure, • Strategic partnership with leading
submissions in the pharmaceutical ISO 27001-certified Infosys Cloud product vendors to provide cutting-
industry • Pay-per-use model based on edge technology solutions
• Hosted end-to-end solution that usage volume with minimal initial • Right mix of expertise in technology
leverages best-in-class commercial- investment and business domain consulting
off-the-shelf (COTS) products as • Reduction of total cost of ownership to craft innovative and extremely
standard interfaces with a unified user (TCO) powerful business solutions
interface • Single point of ownership and
Flexible and current
• Service-oriented architecture (SOA) accountability to
• Flexible framework that enables
layer to seamlessly integrate with Keep solution, technology, and
seamless integration with client’s
other enterprise systems infrastructure up-to-date and
existing systems and tools
• Secure framework that addresses regulatory-compliant
• Expandable cloud-based infrastructure
pharmaceutical security and privacy End-to-end support service with
that matches usage expansions and
requirements minimal ticket transfers
performance standard
Single-point support

For more information, contact [email protected]

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