8 September 2021: Navitas Life Sciences, a TAKE Solutions company, announces that it has achieved its 200th customer win for its innovative Regulatory Technology, pharmaREADY® driving accelerated compliance and delivering first-time-right submissions.
With regulatory requirements having evolved, becoming more complex, costly, and global in scope life sciences companies are being forced to compete, innovate, and execute faster than ever before. First launched in 2005, pharmaREADY® is a fully integrated, regulatory compliant, web-based platform to create, view, and manage global regulatory submissions. We continue to evolve our technology to ensure a robust product suite with multiple modules including: Document Management System (DMS), electronic Common Technical Document (eCTD), Structured Product Labeling (SPL), and Training Records Management System (TRMS), to meet global regulatory requirements.
Key Benefits of utilizing the pharmaREADY® product suite include:
* Integration | Seamlessly integrates all modules enabling submissions to be prepared in 40% less time than other systems.
* Cost Effective | Lowest Total Cost of Ownership in the industry when compared to other system having similar features and functionalities.
* User Friendly | An intuitive and easy to use product suite that is less prone to mistakes from users.
* Simple and Fast Implementation | The application can be up and running within 3-4 weeks with complete validation
* Training and 24/7 Support | Post end user training, our team of regulatory experts will be available for the first submission to ensure that users are competent with the use of the system. Post Go-Live, experienced support personnel are available 24/7 providing world-class application support.
* Always Ahead | Timely updates for Navitas Life Sciences will keep pharmaREADY® current with ever changing regulatory guidelines and technology innovations.
* Guaranteed Compliance | Compliance with 21 CFR Part 11, Annex 11, cGMP, and HIPAA ensures that companies will always be inspection ready.
* Data Migration | Simple data migration utilities to migrate legacy data including documents, submissions, and labels in a batch, with no user intervention required, saves time.
* Backward Compatibility | Allows old methods to be used, especially to correct mistakes while performing Life Cycle Management (LCM) on imported legacy submissions.
“The pharmaREADY® technology, combined with a team of experts who are truly committed to enhancing the experience of our clients; with hands-on support and sharing of knowledge of regulations and best practices, makes a highly attractive and compelling proposition. We are proud to be able to offer this proposition to 200+ clients across the globe.” Marty Boom, Global Head of Regulatory and Safety, Navitas Life Sciences.
“We have been working with pharmaREADY® for more than 10 years and are very pleased with the user-friendly software which meets ICH expectations and is well prepared to support regulatory publishing for several markets. Where we have needed support for specific situations, the pharmaREADY support team has always provided a fast response and solutions which is critical when working with authorities adhering to strict dates and unpredictable requests.” Rui Custódio, Regulatory Affairs Manager – Technical Affairs, Hikma
For further information on pharmaREADY® please visit: www.pharmaready.com
About TAKE Solutions
TAKE Solutions is a full-service CRO & technology company supporting pharma, biotech and devices companies across the globe.
In the fast-growing Life Sciences space, TAKE offers clients a unique combination of full-service Clinical Research, Generics Development, Data Sciences, Regulatory Affairs, and Pharmacovigilance/Safety services backed by unique technology expertise. Our range of services span from clinical trials to regulatory submissions to post-marketing safety, all backed by insights derived through proprietary industry networks forums. With a team of leading Life Sciences experts, best-in-class systems and processes, and bespoke, industry-specific technology and analytics, TAKE delivers successful outcomes for clients. Our global roster of clients includes large and small innovator biopharmaceutical and devices companies as well as generics manufacturers.
With operations spread across the globe, TAKE is a Public Company, listed in India on the Bombay Stock Exchange and the National Stock Exchange.
For more information, please visit www.takesolutions.com
About Navitas Life Sciences
Navitas Life Sciences delivers platform-driven full-service Clinical, Regulatory, and Safety solutions and services. As the dedicated life sciences brand of TAKE Solutions, Navitas Life Sciences operates across North America, Asia Pacific, and Latin America. Navitas brings together the capabilities of a full-service CRO, a technology-led life sciences services provider, and expertise in analytics and data sciences to address critical challenges and drive outcomes for life sciences.
Navitas has over 30 years of rich experience across 550+ phase I-IV clinical trials, 1100 bioequivalence studies, 20+ therapeutic areas, and 40+ successful GCP/non-GCP audits.
Our trial expertise is augmented by OneClinical, a platform that delivers trial oversight, analytics, and insights to drive successful study outcomes. With over 50 strategic regulatory consulting engagements, Navitas has delivered 180,000+ submissions to a range of regulatory authorities across the globe.
Backed by insights derived from our proprietary industry networks, and over 300 strategic safety consulting engagements, Navitas supports both in-trial and post-authorization pharmacovigilance to ensure better patient safety. Over the last 17 years, our 10 proprietary industry networks have provided a platform for industry peers to share with and learn from each other. With over 120 members, the ‘nets’ drive the development and adoption of industry best practices and innovations.
Navitas Life Sciences brings together the best minds in the industry to provide life sciences companies with an adaptive, innovative, and reliable partner who delivers better outcomes consistently, across the value chain.
To learn more, visit www.navitaslifesciences.com.
For media information, contact:
Rajeswari Pradeep Kumar, TAKE Solutions, Mobile Number: +91 99400 64483, rajeswari.p@takesolutions.com