Query: container closure integrity study methodology
Correspondence from ANMAT regarding ANMAT-2020-0075. Type: query. Risk: low. Category: Quality.
Correspondence ID
COR-175
Type
query
Application
Authority
ANMAT
Category
Quality
Risk
Low
Due Date
2025-03-30
Status
Open
Owner
Dmitri Volkov
Created
2022-10-30
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0075, 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_175.pdfdata_table_175.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.