Regulatory Dossier Preparation
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540
CMC submission packages written
during 2019-2023
Our global regulatory CMC writing teams have extensive experience in preparing regulatory dossiers for IND, IMPD, and NDA submissions with the US FDA, EMA, and China’s NMPA. By integrating CMC dossier writing with our API and drug product development and manufacturing, we can expedite the timeline to IND and NDA. Typically, it takes our team 6-8 weeks to prepare an IND submission package for the US FDA.
We offer dossier writing support in both English and Chinese to facilitate a parallel filing strategy for the US and China.
Small Molecule
Oligonucleotide
Peptide
CMC Writing Streamlined and Integrated as a Part of the Project Team
- Project Initiation: provide RA consultation for phase and modality appropriate, country specific project scope and strategy
- Project Execution: provide filing template, collect data once testing completed. Finish section writing along different phases and perform timely data review with clients to mitigate potential risks
- Project Completion: complete submission-ready CMC dossiers
