Query: container closure integrity study methodology

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0037. Type: question. Risk: high. Category: Nonclinical.

Correspondence ID
COR-237
Type
question
Application
SFDA-2023-0037
Authority
Saudi Food and Drug Authority
Category
Nonclinical
Risk
High
Due Date
2025-04-19
Status
Overdue
Owner
Lieselotte van der Berg
Created
2022-09-30
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0037, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
data_table_237.xlsxattachment_237_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.