2. ECTD
PharmaREADY™ eCTD: A fully integrated web-based Electronic Common Technical Document publishing system, designed to
provide intuitive electronic content assembling, with integrated document management and publishing features. The
pharmaREADY™ eCTD product is designed specifically for the management of complex Document and Submission life cycles
using ICH eCTD standards, scalable technologies, and process oriented methodologies. pharmaREADY™ eCTD is a fully validated
software solution which is compliant with international regulations. PharmaREADY™ eCTD will support all major regional
templates, life cycle management, and consolidated submission reviews. Workflow and role based document authoring and
access management will provide multi-user electronic submission, authoring, and publishing facilities. pharmaREADYTM supports
regulatory submissions to all major regional agencies such as MCC (South Africa), US FDA, Health Canada, EMA (Europe),
Swissmedic (Switzerland), SFDA (Saudi Arabia), and TGA (Australia).
Prominent Features:
Auto-correction of PDF documents to help you handle the detection, notification and correction of required PDF properties
such as Fast Web View, Inherit Zoom for Internal Hyperlinks and Bookmarks, Page View, etc.
Drag and Drop - drag documents directly from your system to the specific section/folder
In place PDF document edit – can create navigation bookmarks and hyperlinks
Features like automated file naming, auto conversion to pdf (agency guided version)
Simultaneous submissions to multiple agencies using custom templates
Comprehensive STF management
Comprehensive Validation Engine
Creation of NeES submission from eCTD
Submission life cycle management as per ICH and regional agency specifications
3. PharmaREADY™ Services –included are these services
PharmaREADY™ Services include 40 hours of remote implementation and training
support, which ensures a smooth and successful pharmaREADY™ solution roll-out.
Full set of IQ and OQ Documentation
Project Plan Development: A dedicated Project Manager will act as the central
point of contact for the entire duration of the project. Navitas’ Project Manager
will work jointly with our customer to develop a comprehensive Project Plan to
maximize efficiency and effectiveness of the pharmaREADY TM system roll-out.
Software Set-up: Navitas provides full software configuration and set-up services
REMOTELY to ensure that the server, along with pharmaREADY TM and the Microsoft
software components are fully functional in the customer’s environment.
System Training: Navitas provides Administrator, individual module user training
and Technical training sessions REMOTELY (web-based, ONLINE), and will also
provide detailed user guides.
Implementation Support: Navitas provides full implementation support, including
but not limited to, helping to define reader groups and roles in a manner that
supports our customers’ operational goals and objectives.
4. Validation Services and Support
The documents provided as a part of our standard validation documentation are:
Computer System Validation
Installation Qualification
Operational Qualification
IQ & OQ Execution
Validation Summary Report
PQ is provided to you
PharmaReady is used by over 110 clients world wide and growing. The suite is a web-based
application and all modules can either be a stand a lone or integrated.
Navitas, is a life science experienced provider in the areas of Clinical,
Regulatory, Safety and compliance-www.navitas.net
