Query: container closure integrity study methodology

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0058. Type: deficiency. Risk: medium. Category: Clinical.

Correspondence ID
COR-558
Type
deficiency
Application
SAHPRA-2022-0058
Authority
South African Health Products Regulatory Authority
Category
Clinical
Risk
Medium
Due Date
2025-01-30
Status
Draft
Owner
Lieselotte van der Berg
Created
2022-07-20
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0058, 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
data_table_558.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.