Regulatory Dossier Preparation
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540
CMC submission packages written
during 2019-2023
Our global regulatory dossier preparation teams have extensive experience in global filings for IND, IMPD, and NDA submissions with the US FDA, EMA, and China’s NMPA. By integrating CMC dossier preparation 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.
TIDES CMC Dossier Preparation Experience
- 20+ INDs for US FDA submission
- 20+ INDs for China NMPA submission
Small Molecule
Oligonucleotide
Peptide
CMC Dossier Preparation 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
