GMP inspection findings clarification
Correspondence from Swissmedic regarding SwissMedic-2021-0069. Type: commitment-request. Risk: low. Category: Administrative.
Correspondence ID
COR-369
Type
commitment-request
Application
Authority
Swissmedic
Category
Administrative
Risk
Low
Due Date
2024-11-27
Status
Open
Owner
Priya Sharma
Created
2022-08-13
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0069, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_369.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-11-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.