Pharma ready ectd

Pharmaready ectd for small to medium size business

1. Pharma Ready ECTD Navitas., INC. 502 Carnegie Center Suite 100 Princeton , NJ 08540 609-720-1002 x231 Client Partner-Penny Coleccio

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. pharmaREADY TM 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