Korean Pharma company TAKEs IND solution

By : |May 31, 2009 0

CHENNAI, INDIA: South Korean Pharma major, IL – Yang Pharm Co Ltd has signed a deal with TAKE Solutions, a Life Sciences and SCM specialist, for IND (Investigational New Drug) submission services.

IND Submission is used to gain FDA (Food and Drug Administration) non-objection to studying the investigational agent in humans.

As a company release, further shares, 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.

L Ramesh, Vice President – Sales, Life Sciences APAC, TAKE Solutions adds that 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, it can 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.”

He further added, "As a part of the deal, we will also represent them in the US FDA as their local agent.”

Yang Pharmaceutical Co. started in Korea in 1946 and has factories in Yongin City and Kunsan City.

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