A renewed focus on exploring newer markets has resulted in TAKE Solutions Ltd. (BSE: 532890), leaders in Supply Chain Management (SCM) and Life Sciences products, signing a major deal with the leading South Korean Pharma major, IL – Yang Pharm Co Ltd. TAKE Solutions will be providing IND (Investigational New Drug) submission services to the Pharma giant.
The purpose of the IND Submission is to gain FDA (Food and Drug Administration) non-objection to studying the investigational agent in humans. The IND submission must include, sufficient preclinical data, including toxicity data; details of the chemistry, manufacturing and controls to provide adequate quality control information for the production of the agent and to describe the mechanism of action of the agent; background and rationale for intended clinical use and proposed protocol for Phase I human use.
The time taken to prepare and submit a well-designed, well-executed IND submission cannot be underestimated. From the time a company has a genuine clinical candidate, itcan typically take at least a two-year time frame to gather sufficient information to file an IND and submit it to the FDA. Companies that devote methodical, systematic attention from day one move far more efficiently toward clinical trials than companies that delay.
Talking about the development, Mr. L Ramesh, Vice President - Sales, Life Sciences APAC, TAKE Solutions said, “Our reworked strategy towards focusing on the Asia Pacific region has received a major boost with IL - Yang Pharma, a 50 year old company, who have been exporting Pharma Products to over 30 countries including US and Europe.” He further added, “As a part of the deal, we will also represent them in the US FDA as their local agent, which further underlines our global credentials and expertise in the Life Sciences space. It is also a tangible proof of the commercial viability and success of our technology solutions, which are designed, keeping in mind the needs of our clients.”
- End -
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 our proprietary, in-depth product know-how and solutions that enable business efficiencies for our 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 16 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 centres located in Princeton, New Jersey.
TAKE Solutions is assessed at Level 5 of the Capability Maturity Model Integration (CMMI) & Level 3 of the People Capability Maturity Model, 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
About Il-Yang Pharmaceutical Co.
Since it took the first step to supply medicines in Korea, in 1946, Il-Yang has been advancing into a top-ranking pharmaceutical company in the world through the establishment of the most advanced factories in Yongin City and Kunsan City.
Having furnished all production lines with KGMP and having led the development and supply of perfect and excellent medicines, which are the highest level of the world, Il-Yang acts as a leader to make Korea an advanced country in medicine through continuous research and development for new medicines.
On the basis of the most advanced medical practice and pharmaceutical dispending and a solid business footing in the Korean market, Il-Yang has exported a variety of pharmaceuticals to approximately 30 countries in the world including the USA and Europe, and has opened an era of local production, by establishing Yangjoo Il-Yang Pharmaceutical Limited Company in China and manufacturing end-pharmaceuticals.
http://www.ilyang.co.kr/english/e_main.htm
Jun 2, 2009
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment