Information request: manufacturing process change justificat
Correspondence from ANMAT regarding ANMAT-2020-0095. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-395
Type
question
Application
Authority
ANMAT
Category
Quality
Risk
High
Due Date
2025-04-19
Status
In Progress
Owner
Lieselotte van der Berg
Created
2022-12-05
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0095, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_395_1.pdfstudy_report_395.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.