Chennai, India, December 4, 2014: TAKE Solutions Ltd., a player in the Life Sciences and Supply Chain Management domains, has announced the launch of PharmaReady 6.0 – the latest version of its web-based electronic Document Management and eSubmission Solution. PharmaReady consists of various modules for the Life Science industry including Document Management, eCTD, Structured Product Label Management, Electronic Trial Master File and Paper Submission. These modules can easily fit into a Life Sciences Regulatory Information Management (RIM) framework. PharmaReady 6.0 provides seamless visibility into the entire regulatory document management lifecycle.
TAKE Solutions’ Life Sciences business addresses the needs of virtual and SMB companies with a unique set of regulatory offerings that allow clients internal staff to focus on higher value strategic initiatives. TAKE Solutions works with clients to define their Regulatory Strategy operational model, then offers services around submissions and report publishing, regulatory information management and labeling and artwork services.
TAKE Solutions works with large global life science companies and developed solutions for smaller Life Science companies, solutions tailored to a smaller company’s needs. New Upgrades to various modules under the PharmaReady umbrella include new Drag and Drop features in the eCTD module as well as providing new regulatory agency support for the countries of South Africa and Australia.
The CFO from a midsized U.S. based pharmaceutical company states “The software (PharmaReady) has been an excellent investment for our company’s FDA electronic filings. We found working with TAKE Solutions a pleasure from installation and validation through ongoing support. We will fully realize return on our investment with their user-friendly product, ongoing support, and periodic training.”
“Starting from preparation to approval, TAKE Solutions’ 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. TAKE Solutions 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”, said Sharath Koripally, Manager – Regulatory Affairs – Citron Pharma.
While eCTD (electronic clinical trial data) is the way forward, the majority of the developed and developing nations still support paper submissions as opposed to electronic. The PharmaReady Paper Publishing Module is included in the PharmaReady 6.0 Suite. This is a complete, web based application solution that helps Life Science companies in creating a paper submission via an array of simple, easy to use screens. The final output is a PDF file that can be submitted to the appropriate regulatory body.
Other TAKE services includes document, report and submission level publishing for both simple and complex submission applications including life cycle management. TAKE provides invaluable subject matter expertise in evolving electronic submissions standards, health authority specific guidelines and processes. TAKE operates a state of the art regulatory processing center. In 2013, TAKE processed over 26,000 submissions to regulatory agencies throughout the world.
PharmaReady is a web-based electronic Document Management and eSubmission Solution suite created by industry experts with real life experience. PharmaReady is designed for both emerging and large Life Science organizations where ease of installation, ease of use, regulatory compliance and affordability are the primary business drivers. PharmaReady was launched in 2006 and is used by companies in the United States, Europe, India and the Middle East by over 80 Life Science organizations.
PharmaReady has a lower total cost of ownership compared to competitive products, is very user friendly and is easy to learn and use. TAKE provides 24/7 customer support and benefits from being designed by domain and technical knowledge experts. TAKE Life Sciences provides free online refresher PharmaReady training programs and works with clients until they are fully and completely comfortable while making their first regulatory submission.
PharmaReady has the fastest rollout time in the industry, requiring just 5 working days to execute the IQs and OQs and training internal staff on its use. Additionally, TAKE Life Sciences provides free consultation in the set-up of the system and the best practices of making the best use of its features and functionalities. Additionally, the eCTD / NeES is SFDA ready and has offices and staff in the Middle East for local representation.