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Regulatory Dossier Preparation
The dossier written by the people who generated the data.
What the team prepares
Our global regulatory CMC writing teams prepare IND, IMPD and NDA submissions for the US FDA, EMA and China’s NMPA, and have submitted more than 1,000 CMC submission packages supporting global IND and NDA filings since 2019.
Substances covered: small molecule, oligonucleotide, and peptide.
Six to eight weeks to a US IND package
A US IND submission package typically takes six to eight weeks to prepare. That is possible because dossier preparation writers are part of the project team, filing templates go out at project initiation, and sections are written as data arrives.
Integrating CMC dossier writing with API and drug product development and manufacturing is what shortens the timeline to IND and NDA.
How the work runs
At project initiation — regulatory consultation on a phase-appropriate and modality-appropriate scope and strategy, by country.
During execution — the filing template is issued, data is collected as testing completes, sections are written across the phases, and data is reviewed with the sponsor as it is generated, so questions surface before the filing is assembled.
At completion — submission-ready CMC dossiers.