DataRevive Experience / 成功经验

我们专精通大小分子药物的法规。 无论您有什么样的产品:经典单克隆抗体,抗体药物偶联,单域抗体, 融合蛋白, 双特异抗体,PEG化蛋白, 抗体-酶融合品, 酶蛋白, 细胞因子,放射元素抗体偶联, 抗体诊断试剂,细胞制品 CART,多肽,小分子化合物;无论是新药还是生仿药;无论是真核,原核细胞表达还是化学合成;只要您设计生产出来,我们都能专业的帮您用最合适的法规途径申报。

Examples of current consulting work:

  • Antibody drug conjugate IND filing package preparation
  • Biosimilar product development FDA advisory meeting preparation
  • Breakthrough product BLA filing
  • Fast track designation request package preparation
  • Orphan drug desingation request
  • Audition of the finished drug product and drug substance manufacturing facilities
  • 505 b(2) application for small molecule
  • Qualified infectious disease product development
  • Pre-approval GMP mock inspection
  • Clinical site monitoring
  • Different IND phase dossier writing and submission including: monoclonal antibody (novel and biosimilar), cell and gene therapy products, insulin and cytokine, live bacteria, and small molecules