(1888PressRelease)
March 26, 2008 - Chennai — Today, TAKE Solutions’ Life Sciences division announced the global expansion of its highly successful Submission Consulting Services unit to include North America, Europe, Asia/Pacific and Australia. The newly redesigned services unit is in response to market demand for its high-value Submissions Consulting services to provide direction and assistance in compiling error free submissions.
TAKE Solutions’ Submissions Assurance™ Programs will now offer two uniquely targeted Submission Assurance delivery models. One Submissions Assurance™ offering will be available to TAKE Solutions’ customers that license TAKE Solutions’ PharmaReady™ eCTD software solution. A separate Submissions Assurance™ delivery model is available to customers that want to fully outsource this service without the requirement of licensing any software. In this instance, TAKE Solutions’ submission services group will utilize its PharmaReady™ eCTD software solution, internally, as part of a fully outsourced solution.
“The FDA mandate for regulated life sciences organizations to submit IND’s and NDA’s electronically, is requiring these fast-moving organizations to seek assistance from trusted partners,” stated Robert MacDougall, Executive Vice President, Sales & Marketing. “Now adding to this, EMEA requirements for electronic submissions beginning in 2009, has created even greater demand for our Submission Assurance™ services.”
Submissions Assurance™ key deliverables include but are not limited to the following:
1. Develop Submissions Project Plan & Roadmaps
2. Ensure Agency Specific Document Formatting & Publishing
3. Develop CTD Structuring and Document Content Plan
4. Provide Submission Compilation and Life Cycle Management
5. Support and Manage Pilot Submissions
6. Perform as Regulatory Agency Liaison
“For companies looking to get off the ground right away at a reasonable, fixed price this is the perfect service”, stated Suren Dheenadayalan, Director of TAKE Solutions’ Submissions Services unit. “We are excited that through the expansion of our consulting team we’ll be able to offer this on a larger scale,” continued Suren Dheenadayalan. TAKE Solutions’ vast knowledge and experience with the global regulatory agencies, life sciences domain, and enabling technologies, makes us uniquely qualified to deliver high-value to our customers in this mission critical business area.”
About PharmaReady™
PharmaReady is a fully integrated web-based product and services solution suite including Document Management, Training Records Management, Structured Product Labeling and eSubmission Services. PharmaReady is specifically designed for life science organizations where ease of installation, ease of use, Part 11 compliance, and affordability are the primary business drivers. The PharmaReady solution suite is designed specifically for management of SOPs, work instructions, training records, submission documents and all other documents within business areas regulated by the FDA. PharmaReady is a fully 21 CFR Part 11 compliant solution based on Microsoft Windows technology.
www.PharmaReady.com
About TAKE Solutions
TAKE Solutions is a leading international business technology company with products backed by a strong domain expertise in Life Sciences and Supply Chain Management - to provide cost-effective, comprehensive solutions for businesses. The vision of the company is to drive industry best practices through proprietary, in-depth product know-how and solutions that enable business efficiencies for clients. Since its inception in 2000, TAKE has been serving marquee clients in the Life Sciences and SCM arena. TAKE Solutions conducts business today in 12 countries with more than 300 customers.
Headquartered in Chennai, TAKE primarily drives its SCM Domain Excellence Centre and Global Delivery Centre from India. Company has strong presence in the USA with Life Sciences Domain Excellence centers located in Princeton, New Jersey.
TAKE Solutions is assessed at Level 5 of the Capability Maturity Model Integration (CMMI), Software Engineering Institute, Carnegie Mellon University, USA. TAKE Solutions is a Microsoft Gold Certified Partner, a Charter Member of the Microsoft BioIT Alliance, and is a Registered CDISC Solution Provider.
www.takesolutions.com (BSE/NSE Code: TAKE)
**Contact TAKE Solutions for the complete details and restrictions of this offer.
Press Contacts:
Ms.Preethi Shankar
TAKE Solutions Ltd.
Tel: 044 - 6696 3204
preethishankar ( @ ) takesolutions dot com
Mr. Pradeep Singh
Adfactors PR Pvt. Ltd.
Cell: 9958431199
Pradeep.singh ( @ ) adfactorspr dot com
