Chennai-based Take Solutions has struck a deal with IL-Yang Pharmaceutical Company of South Korea, under which Take will provide ‘investigational new drug submission services’ to the pharma company. The purpose of the IND submission is to gain FDA (Food and Drug Administration) non-objection to study investigational agent in humans. The IND submission must include, sufficient preclinical data, details of the chemistry, description of mechanism of action of the agent, background and rationale for intended clinical use and proposed protocol for Phase I human use, says a press release from Take. “As a part of the deal, we will also represent them in the USFDA as their local agent, which further underlines our global credentials and expertise in the Life Sciences space,” says Mr L. Ramesh, Vice-President (Sales), Life Sciences division, Take Solutions.
Source: The Hindu BusinesslineTake Solutions deal with Korean co
Industry: Pharmaceutical 2016-04-03
