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pharmaREADY, Your Regulatory Compliant Document Management& eSubmissions Suite

The pharmaREADY suite is a web-based electronic Document Management and eSubmission platform. pharmaREADY consists of various modules for the Life Science industry including Document Management, eCTD, Structured Product Label Management and Paper Submission.

These modules easily fit into a Life Sciences Regulatory Information Management (RIM) framework. pharmaREADY provides seamless visibility into the entire regulatory document management lifecycle.

“Maximum Value” — Your Bottom Line The next innovation in information management isn’t about a new set of features, it’s about making information management practical and affordable for regulated organizations. With pharmaREADY, you get the power of leading information management systems — at a fraction of the cost.

“Get It Done Now” — Your ImplementationEven better, the effort to get the system in place won’t leave you wondering whether your implementation will be finished before the next release of the software. The bottom line? With pharmaREADY, you get a suite of information management solutions like document management, label creation, and eCTD management that will be up and running in days, not months.

“Unmatched Innovation” — Your SuccessSo how did we do all this? We’ve taken Microsoft Windows and SQL Server platforms — combined over two decades of life sciences business expertise — to offer the first fully integrated Pharma one-stop product suite that meets your regulatory compliance requirements.

pharmaREADY CORE CAPABILITIES

Central Repository Store information in centralized, secure libraries with customizable folders.

Collaborative Workflow Manage documents throughout their lifecycle: creation, review, approval, distribution and archival with automated version control.

Publish and Distribute Publish documents as PDFs and manage their distribution quickly and easily.

Clients talk about pharmaREADY

“pharmaREADY has been an excellent investment for our company’s FDA electronic filings. We found working with Navitas Life Sciences a pleasure from installation and validation through ongoing support. We will fully realize return on our investment with their userfriendly product, ongoing support, and periodic training.”

- CEO of US based Pharma Company

“Starting from preparation toapproval, Navitas Life Sciences’ pharmaREADY is compliant with the regulations, easy to use and has better managerial controls than some other eCTD solutions on the market. pharmaREADY is affordable to many Pharmaceutical companies out there. Navitas Life Sciences provides great customer service when issues arise, and pharmaREADY is one of the best eCTD tools that I have used during my tenure for a much better price”

Sharath Koripally, Manager - Regulatory Affairs – Citron Pharma.

On Premise or in the Cloud

pharmaREADY gets up and running quickly, either at your location or in the cloud. Navitas Life Sciences can host your pharmaREADY version on Amazon Web Services (AWS) globally, so your data will be local, no matter where you are located. pharmaREADY on AWS comes with strong security, and doesn’t require hardware or software purchases. There are no Annual Maintenance Fees, and you just pay for the number of users you need monthly.

PR DMS Document Management System

Web-based electronic document management specifically designed for life science organizations where ease of installation, ease of use, Part 11 compliance, and affordability are the primary business drivers. Specifically designed for the managementof eCTD leaf documents, label documents in SPL formats, SOPs, work instructions, and all other documents within business areas regulated by the FDA.

PR eCTDElectronic Common Technical Document

Intuitive electronic content assembling with integrated document management and publishing features. Supportsall major regional templates,life cycle management and consolidated submission reviews. Workflow and role based document authoring and access management provides multi-user electronic submission, authoring, and publishing.

PR SPL Structured Product Labeling

Simple copy paste label authoring, supporting complex content structures including tables, lists, special characters and nested sections. Context sensitive FDA guidelines provided for each label section. Automated data element validations to ensure FDA compliance. Supports generation of NDC Labeler Code and Establishment Registration. Enables generation of Drug Listing for Over the Counter(OTC) products and Animal & Veterinary medicines.

PR TRMS Training Records Management System

pharmaREADY TRMS is designed specifically for managementof training related to SOPs, Work Instructions, and other Specifications documents within business areas regulated bythe FDA. It can also be used for documenting any other employee training within your organization.

Ready to explore how Navitas Life Sciences can make your business more efficient, proactive, and flexible?

Contact us at 609-720-1002, or visit us online at www.pharmaready.com

Role-Based Manage security and access rights based on flexible user roles.

Templates Create templates like regional templates or document templates to standardize your information.

Audit Trails Track all document and user activity with automatic auditing.

Electronic Signatures Apply electronic signatures on critical activities like document approval.

Single Sign-On Secure access to all pharmaREADY products through one unified logon.

PR PPM Paper Publishing Module

pharmaREADY PPM helps pharmaceutical companies in creating a paper submission via an array of simple to use screens. The final output is a portable document format (PDF) file that can be printed and submittedto the appropriate regulatory body. It also helps one to save the output in a CD and submit it as NEES (Non eCTD Electronic Submission) submission, which still is a widely accepted form of submission for many EU countries.

pharmaREADY is an exclusive brand of Navitas Life Sciences

A TAKE Solutions Enterprise

For more information502 Carnegie Center, Suite 100, Princeton, NJ 08540

USA +1 609 720 1002 EU +49 69 668 0300 India +91 44 4590 9000email contact@navitaslifesciences.com or visit www.navitaslifesciences.com

About Navitas Life SciencesNavitas Life Sciences brings together the proven strengths of its legacy brands Navitas, Ecron Acunova and Intelent to serve as a strategic partner to global Life Sciences companies. Navitas life Sciences leverages its industry insights and domain expertise to develop and implement consulting, technology and functional services across the spectrum of Clinical, Regulatory and Safety, to innovative and create value to address the needs of the industry uniquely.

© Navitas Life Sciences

®About NavitasWe are domain experts in the areas of Clinical, Regulatory, Safety and Compliance. We pride ourselves on our industry insight, our simplification approach and our pragmatic solutions. Our capabilities cover; industry leading networks, strategic and change management consulting, technology and BPO. We are motivated by the success of our clients; improving outcomes, ensuring compliance and enabling growth.

For more information

USA +1 609 720 1002 EU +44 2392 268133 India +91 44 4590 9000

email contact@navitas.net or visit www.navitas.net

Services

pharmaREADY is designed and used by small and medium life science companies for their regulatory needs. Not all companies are ready or have the resources available to utilize pharmaREADY. For those companies, Navitas offers pharmaREADY Services, which include:

Submission Publishing

IND, CTA, BLA, ANDA, DMF Original Submissions

US IND, NDA Amendments, Promotional Submissions & Annual Reports

US Safety Submission EU eCTD, Centralized/Mutual Recognition Procedure/Decentralized Procedure, Life Cycle Submissions

EU NeeS, Merged PDF, Life Cycle Submissions

SPL Conversion & Submission through ESG

SPL New Label in R4 SPL RF Conversion-Revision

SPL Establishment RegistrationSPL NDC Labeler Code Generation

SPL NDC Labeler Code Generation - Revision

Submission through Navitas ESG Gateway