A renewed focus on exploring newer markets has resulted in Take Solutions Ltd., 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. The company 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 took 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.
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."
"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," he added.