Regulatory Dossier Preparation

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CMC submission packages written during 2019-2023

Our global regulatory CMC writing teams are experienced in regulatory dossiers preparation for IND, IMPD and NDA submissions with US FDA, EMA and China NMPA. Integrating CMC dossier writing with our API and drug product development and manufacturing can accelerate the timeline to IND and NDA. It usually takes our team 6-8 weeks to prepare IND submission package for US FDA.

Small Molecule



Streamlined CMC writing integrated as part of the project team

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