Sphinx Scientific Laboratory (TianJin) CO.,LTD. sell "CMC"

Services cover contract research, development and analysis in support of regulatory dossiers and corresponding registration applications: production process studies; route investigation and determination at lab and pilot scale; control of key starting materials and intermediates; process transfer; characterization; API structure identification; impurity synthesis, isolation and structure identification (NMR/LC-MS/MS/IR/UV); quality research; analytical method development, validation, transfer and re-validation; specification development and establishment; working standard qualification; stability studies, including influencing-factor, accelerated and long-term stability studies; and registration applications, including local drug registration filings, DMF drafting in CTD format with CMC dossier submissions, and consultation on Chinese registration regulations plus assistance with on-site inspections.