Query: container closure integrity study methodology

Correspondence from Health Sciences Authority regarding HSA-2023-0032. Type: question. Risk: high. Category: Administrative.

Correspondence ID
COR-232
Type
question
Application
HSA-2023-0032
Authority
Health Sciences Authority
Category
Administrative
Risk
High
Due Date
2025-04-10
Status
Open
Owner
Nadia Petrova
Created
2023-03-12
Correspondence Body
Dear HSA Review Team, With reference to application HSA-2023-0032, we wish to address the following: [Detailed response body regarding request for updated smpc section 4.1] 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: 2025-04-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.