TAKE Solutions Ltd.
announced the availability of PharmaReadyTM 5.0, a web-based regulatory compliance solution suite for Life Science organizations to ensure faster approvals for their new products. The latest version introduces new document management features, and delivers technology framework upgrades to enhance scalability, response time, and ease-of-use.
PharmaReady 5.0 supports submissions to Swissmedic (in addition to US FDA, Health Canada and EMEA). It comes with an improved dashboard for easier navigation and management of documents from a centralized location, provides more visibility and control of e-document/e-submission processes, and introduces new functionalities including drag and drop for quicker document uploads. In addition, PharmaReady 5.0 includes an enhanced, highly scalable technology framework allowing the suite to run seamlessly on any Microsoft platform.
Speaking on the occasion, Ram Yeleswarapu, President and CEO, TAKE Solutions, said, “TAKE Solutions has understood the pulse of the life sciences market and has worked persistently towards achieving the goal of better value to our customers. Having used both our IT expertise, as well as our domain knowledge, we are proud to release the upgraded version PharmaReady 5.0” He added, “PharmaReady is a stable and growing product line that has been consistently delivering value to our customers across the globe.”
“TAKE is committed to diligently listening to our customers as well as regulators, partners, and competitors,” stated Mike Lewis, Vice President –Life Sciences, TAKE Solutions. “This release is a key milestone marking our continuous efforts to add value and bring significant and relevant global regulatory standards to our life sciences customer base by acting as a key liaison, thought-leader, and solution provider in this space.”
The PharmaReady solution suite is designed specifically for management of SOPs,work instructions, training records, document and submission publishing in the eCTD and other formats, as well as to manage other electronic documents. PharmaReady is in full compliance with global regulatory requirements and was designed to be an easy to use, easy to deploy, and affordable solution.
PharmaReady has a record of 100% submission acceptance by regulatory authorities, and this is attributed to four key factors: comprehensive solution that meets the latest requirements, out-of-the-box implementation with minimum start-up time, compliance enabled, and a top-notch support team.
Pharmaready has a no. of global customers including Pharmaceutical, Medical device Companies, and CROs. A majority of regulatory submissions by Indian Pharma manufacturers are done using Pharmaready products or related services from TAKE.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.