1. Formulation design of oral, parenteral and topical product.
2. New drug delivery platform development for 505(b)2 candidate.
3. CMC preparation global submission.
4. Patent survey for new candidate and by-pass formulation design.
5. Trouble-shooting of existing commercial products.

1. 新藥與學名藥的處方篩選之方法開發及運用
2. 成品分析方法開發, 方法確效(validation), 檢驗規格設計與化驗工作
3. 原料藥, 賦形劑分析方法測試, 檢驗規格設定, 方法確認(verification)與化驗工作
4. 運用US, EU, JP, CN, KR和TW等各國法規, 配合ICH及GMP規則, 撰寫及審閱CMC相關文件, 以及國內外查驗登記之回覆相關檢驗工作
5. 分析技術之開發, 國內外之技術轉移
6. 對研發有強烈的熱忱及興趣者尤佳, 我們的環境和歷練可訓練您成為業界頂尖的研發人員

1.開發調整分析方法(HPLC, GC, IC…)，協助產品製程開發，分析方法之確校；2.執行實驗室設備3Q；3.研擬審查藥典相關產品規格及分析測試，建立藥典規格；4.操作化學分析儀器進行分析，協助產品放行…

1.Facilitate Lot disposition process, reviewing GMP docs and managing timelines；2. Support day-to-day Quality Assurance – Operations；3.Perform batch disposition activities within specified timelines…

1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory…

1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory…