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服務與生產平臺
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上海博志研新藥物技術有限公司建設的化學藥物及其中間體合成、制劑研發、臨床試驗、一致性評價及注冊申報一站式公共服務平臺是面向張江、面向上海和全國醫藥產業,為制藥企業、科研院所等提供原料藥合成、原料藥中間體供應、原料藥雜質供應、制劑研發、質量標準建立、工藝交接、中試放大服務、臨床試驗和一致性評價等一站式服務。博志研新經過多年的創新研發活動,不但積累了大量的關鍵核心技術,培養了一支專業覆蓋廣、實戰能力突出的技術服務團隊,還建成了一整套集藥物以及中間體合成、新型制劑研發、制劑分析測試的小、中試交接、臨床試驗、一致性評價和藥品注冊為一體的公共服務平臺。


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可提供全面的研究服務

●    立項可行性分析:專注未被滿足的臨床需求
●    原料藥工藝開發、晶型研究、雜質控制、產業化
●    制劑工藝開發、工藝優化、產業化
●    質量研究:分析方法開發、基因毒性雜質研究、方法學驗證、質量標準
●    注冊申報:資料撰寫、研制現場考察、CDE溝通
●    臨床研究服務:項目管理及臨床監察、醫學撰寫、數據管理和統計分析、項目稽查、CRC派遣


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