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.
We also support writing in both English and Chinese for US and China parallel filing strategy.
Small Molecule
Oligonucleotide
Peptide
Streamlined CMC writing integrated as 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
Related Resources
Securing New Drug Development by Establishing and Maintaining Phase-appropriate RSM Designation from Development to Commercial Launch
