Biological Testing Method Development and Licensing Support
The following items are included in the biological testing methods(development of the test method for biological drug) and (Support of MFDS approval) licensing support services provided by SLS Bio.
Non(Pre)-clinical trial (study) design
Development of manufacturing process
(IPC, separation process, etc.)
Development of specification and test method of biological drug that fit the characteristics of the development formula
Testing inspection (stability, investigational drug, etc.)
IND dossier completion (support)