創新藥制劑CRO/CMO

新藥制劑委托研發

一站式CRO與CDMO服務

• 提供新藥毒理研究制劑、I~III期臨床樣品與商業化產品生產服務
• 美國FDA與中國NMPA雙認證的GMP設施與質量系統
• 經驗豐富的專業團隊，擅長制定契合目標的產品開發策略與解決難溶性藥物開發難題
• 提供中美歐等國家地區的IND與NDA注冊資料撰寫服務
• 國際接軌的設備儀器與嚴格的數據完整性體系，共同保障質量合規
• 具備常規及高活性口服固體生產線

“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