Question on comparative dissolution data
Correspondence from Swissmedic regarding SwissMedic-2021-0029. Type: query. Risk: medium. Category: Quality.
Correspondence ID
COR-129
Type
query
Application
Authority
Swissmedic
Category
Quality
Risk
Medium
Due Date
2025-01-21
Status
In Progress
Owner
Carlos Mendez
Created
2023-12-06
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0029, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.