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Integrated Services
Three services that run alongside every stage of a program, in the same organization as the chemistry.
Coordination across the workstreams
A CMC program needs analytical method development, a regulatory dossier, and a single point of accountability for the timeline. Each can be contracted separately.
Separate suppliers mean separate specifications, analytical method transfers, audit trails and project managers, each accountable for one piece of the program and none for the date.
At WuXi Chemistry, the three services below run in the same organization as the chemistry.
Project Management
One project manager with authority across drug substance, drug product, and analytical, accountable for the timeline rather than for a workstream.
Analytical
Method development, validation, QC release and stability, for drug substance and drug product, across small molecules, peptides, and oligonucleotides. More than 12,500 chromatographic and 2,300 non-chromatographic methods developed a year, and more than 39,000 drug substance and 3,800 drug product batches released in twelve months.
Regulatory Dossier Preparation
IND, IMPD and NDA submissions for the US FDA, EMA and China’s NMPA. More than 1,000 CMC submission packages written since 2019, with a US IND package typically prepared in six to eight weeks.
Project Management
One project manager with authority across drug substance, drug product and analytical, accountable for the timeline rather than for a workstream.
Inspection history
More than 30 pre-approval inspections waived by the US FDA and EMA since 2023. Across WuXi STA and WuXi TIDES:
30
12
95
17
4
6
One organization for three services
A fragmented CMC supply chain has a coordination cost that does not appear on a quote: separate suppliers held to one timeline by the sponsor. Three services in one organization removes that work from the sponsor’s side.