新藥制劑委托研發(fā)
一站式CRO與CDMO服務(wù)
- 提供新藥毒理研究制劑、I~III期臨床樣品與商業(yè)化產(chǎn)品生產(chǎn)服務(wù)
- 美國(guó)FDA與中國(guó)NMPA雙認(rèn)證的GMP設(shè)施與質(zhì)量系統(tǒng)
- 經(jīng)驗(yàn)豐富的專(zhuān)業(yè)團(tuán)隊(duì)，擅長(zhǎng)制定契合目標(biāo)的產(chǎn)品開(kāi)發(fā)策略與解決難溶性藥物開(kāi)發(fā)難題
- 提供中美歐等國(guó)家地區(qū)的IND與NDA注冊(cè)資料撰寫(xiě)服務(wù)
- 國(guó)際接軌的設(shè)備儀器與嚴(yán)格的數(shù)據(jù)完整性體系，共同保障質(zhì)量合規(guī)
- 具備常規(guī)及高活性口服固體生產(chǎn)線(xiàn)
“One-Stop” Drug Product Development CRO and CDMO Service
- Manufacture of Tox, Phase I-III Clinical Samples and Commercial Supply
- US FDA and NMPA Compliant Quality System and GMP Facilities
- Experienced Professional Team, Specialized in Fit-for-Purposed and/or Problem-Solving Formulation for Poorly Soluble Compounds
- INDs and NDA Documents & Dossier Preparation for China, US and Europe Regulatory Agencies
- State-of-Art Equipment and Instruments, Excellent Data Integrity System to Ensure Quality and Compliance Outcome
Separated Oral Dosage Production Line for Regular and High Potency Drug
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