Services & Solutions
Regulatory Dossier Preparation
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…
740+
CMC submission packages written during 2019-2024
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
Why WuXi TIDES
What this platform adds
Scalability
From discovery to commercialisation entirely within WuXi TIDES, with readily available large R&D and manufacturing capacity.
Conjugation Chemistry
Seamless collaboration across the oligonucleotide, peptide and small molecule teams — the conjugates nobody else wants to touch.
New Technology
Biocatalysis for gRNA synthesis, thin film evaporation, reactor-in-series with PAT, continuous flow chromatography, TFF.
Global Quality Standard
One quality system across every site, approved by the major regulatory agencies around the world.
Comprehensive Analytical
Method development and validation, IPC and release testing, characterisation and stability under one roof.
Integrated CMC
API and formulation development, manufacturing, analytical, dossier preparation and clinical supply as a single programme.
Meeting global quality standards
Inspection record
How can we help?
Our TIDES drug experts stand ready.
Tell us where your molecule is today — discovery, CMC, or commercial supply — and we will map the fastest credible route to patients.
Small molecule projects? WuXi STA