1. Flexible, Cost-effective, Proven Solutions
pharmaREADY
Flexible, Cost-effective, Proven Solutions

2. pharmaREADY – Navitas’ Proprietary Product Suite
Brand name established in 2006
Running successfully for 12 plus years
Started with version 2.x; Current version is 8.x (Next Generation)
170 plus customers worldwide
Customer base across APAC, Europe, North America and Middle East
24 x 7 Customer Support

3. pharmaREADY Customer base from 2006 to 2018

4. pharmaREADY Demographics
170+
Customer Logos
Up to 10000
User Base
Upto 1.5 Mn
Documents Handled
Upto 1,75,000
Submissions Managed
Up to 7500
SPL Managed

5. pharmaREADY – Navitas’ proprietary document management and eSubmissions suite
DMS
Document Lifecycle Management
Management of SOPs and Work Instructions
Fully integrated web-based DMS, Training
Records Management, SPL & eCTD Publishing product suite
Built on Microsoft’s scalable .NET framework / SharePoint
Designed specifically for regulated Life Science organizations
21 CFR Part 11, cGMP and HIPAA compliant compliant
170+ customers world wide
Integrates with best-of-breed apps like Trackwise & DCTM
eCTD
Regulatory Submission Management
Support for FDA, EMA, Health Canada, Swiss Medic, MCC, TGA, THAI FDA, Jordan and Saudi FDA
SPL
Comprehensive label creation and management
Establishment registration and NDC Labeler Code
TRMS
Training records management
Manage assessments, job specifications, and requirements
PPM
Paper Publishing Module
Creates paper submission for Non eCTD Electronic Submission (NeeS)

6. pharmaREADY™ eDMS Automated Numbering
Revision Control
Complete Audit Trail
Audit Logs
Electronic Signature
Custom Standardized Templates
Scheduled Publishing
Control & Track Distribution
Easy Access
Fully Integrated with eCTD & TRMS
Audit Log Viewer
Groups (Approver, Reviewer, Reader)
Configuration of Templates
Comprehensive document properties
Competitive Pricing
Specifically designed for Life Sciences organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers
Manages document lifecycle process and gives the tools to securely manage a wide range of business documents, including those related to regulated environments
Fully 21 CFR Part 11 compliance and built on stable Microsoft Technology
24/7 Customer Support

7. pharmaREADY™ eCTD One stop regulatory submission management solution
Document Management
Dossier Compilation
Submission Project Management
Manage submission dossiers from globally distributed units
Clone & reuse existing submissions
Complete workflow with all the stakeholders within the organization
Guidance & support until successful submissions acceptance at MoH
24/7 Customer Support
Support for FDA, EMA, Health Canada, Swiss Medic, MCC, TGA, THAI FDA, Jordan and Saudi FDA
Simultaneous submissions to multiple agencies using comprehensive templates
Submission life cycle management as per ICH and regional agency specifications
Module templates compliant with latest ICH and Regional specifications
Comprehensive STF management
Automated File naming for all modules based on ICH and Regional file naming guidelines
True Drag and Drop for easier assembly
Comprehensive Validation Engine
Creation of NeES submission from eCTD
Competitive Pricing

8. pharmaREADY™ SPL
Comprehensive label creation and management comprising
Content Management
Content Reuse
Label Project management
Fully implemented PLR
Guaranteed compliance with SPL R4 Schema and guidelines
Complete workflow with all the stakeholders within the organization
Guidance & support until successful submission
Establishment Registration and NDC Labeler Code included
24/7 Customer Support
Zero footprint, easy to use, web based interface with no plug-in required
User friendly with MS-Word like interface
Content reuse by creating custom templates
Labeling life cycle as per the SPL specifications
Reference code lookup for highlights and drug listing data elements
Automatic conversion from SPL to PLR
Better content management control
Easy to create tables, footnotes, ordered lists, etc
Enriched and Improvised User Interface across the application

9. pharmaREADY™ TRMS
Specifically designed for management of training related to SOPs, Work Instructions, and other Specifications documents within business areas regulated by the agencies
It can also be used for documenting any other employee training within your organization
24/7 Customer Support
notifications to both Employees and Supervisors
Customizable, on-line assessments with results automatically reported
Automatic notification of retraining when Specifications are updated
e-Signatures for updating training records when needed
Training management at the Employee, Supervisor, and/or Department level
Executed Installation and Operational Qualification documents
Administration Manuals

10. pharmaREADY™ PPM
Assemble & organize Submission Documents based on Volumes, Modules and Agency specific classifications
Import documents from existing eCTD Submission
Accepts all common MS office document formats in addition to PDF
Create Agency specific submission structure and compile documents
Create Volume, Module Headers, Separators & Global, Volume & Module TOCs
Create Continuous / Volume / Module based page numbers
Preview the print ready documents
Print final submission ready dossier
Streamlines the complex process involved in preparing paper based dossiers for submissions to non regulated markets
A good start to migrate towards the paper less electronic submissions in the near future
Ease of implementation and use, requires minimum start up time
Highly cost effective solution
24/7 Customer Support

11. Right mix – Strong Compound !

12. pharmaREADY 8.x Mock-up Screens
Highlights
Bringing aesthetic look and feel by the way of reskinning all PR Suite modules screens
Enriching User Experience across all modules of PR Suite
Crafting few functional screens using Responsive Design [Targeting for Desktops, Tablets & Mobile phones]
Amplifying PR Suite performance wherever is required
Augmenting additional functional features

13. Salient Feature of pharmaREADY 8.x (eCTD)
User Profile
Permission based Regulatory body metadata creation (regional / local) guidelines
Personalized Submission Dashboards covering regulatory body, status, application or submission type
Faster Submissions
Multiple envelopes creation
Faster excipients sections creations
Incremental Compile
Module-wise compilation
Latest View of Dossier for easy life cycle management
PDF Enhancements
Bulk Bookmark / TOC creation
Header \ Footer creation in Scanned Documents
Validations for In-active Bookmarks and Hyperlinks

14. Salient Feature of pharmaREADY 8.x (DMS)
Enhanced User Profiling
Personalized Dashboards for Action items
Reminders on Shorty Expiry/Due for renewal Documents
Quick access to frequently accessed Document Listing
Configurable password policy definition
Enhanced Templates Management
Dynamic Metadata configuration for Document Templates
BMR & BPR Templates creation for Batch Manufacturing
Enhanced Doc. Authoring Life Cycle
Mobile based review & approval
Consolidated Review & approval Comments
Document Comparison between versions
Documents Issuance through an approval process
Metadata-based Bulk Documents Import

15. pharmaREADY Roadmap Strategy *
PharmaReady Release Plan Finalization (Major Version / Minor Version)
Technology Upgrades
Market Inputs
Customer Requests
Major Version Rationale (1 to 2 Years)
Regulatory / Statutory Compliance
Significant feature additions
Significant Technical Enhancements
Design Change
Minor Version Rationale (Quarterly)
Cosmetic feature addition
Minor features
Existing feature refinements
Issue Fixation (Based on Triage)
Hot Fix (Need based)
Time bound Issue Fixes
Note (*)
Roadmap Features are subject to inclusions/exclusions and reprioritization based on Product Management Group recommendation
Integration with third party systems is achieved through web-services or external data adapters based on project needs

16. Thank you