Query: container closure integrity study methodology
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0096. Type: information-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-296
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Nonclinical
Risk
Medium
Due Date
2024-12-06
Status
Draft
Owner
Priya Sharma
Created
2023-07-19
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0096, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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: 2024-12-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.