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Regulatory Affairs, Pre-clinical service

- drug testing,(pre)clinical service, drug development ¼­ºñ½ºµî ºÐ¾ß¿¡¼­ °íÇ°Áú ¼­ºñ½º¸¦ Á¦°øÇÏ°í ÀÖ½À´Ï´Ù.

- ±¹³»¹× ±¹Á¦ÀûÀÎ ±âÁØ¿¡ ¸ÂÃç ÀǾàÇ°°³¹ßÀ» À§ÇÑ ÀûÀýÇÑ active ingradient¿Í formulationÀ» ãÀ» ¼ö ÀÖµµ·Ï µ½°íÀÖ½À´Ï´Ù.

1) Method development/validation,transfer method, batch release

2) Pharmacological study, PK, PD, TK, GLP, Identification of unknown impurities

3) In-vitro testing(In-vitro release testing, in-vitro permeation testing)

4) API sourcing: recommend related supply of API ; projects based on requirement

5) API synthesis development, stability studies(GMP, ICH)

6) Small scale synthesis, formulation development