Query: container closure integrity study methodology
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0020. Type: query. Risk: high. Category: Clinical.
Correspondence ID
COR-020
Type
query
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
High
Due Date
2025-01-19
Status
Completed
Owner
Marcus Webb
Created
2022-06-27
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0020, 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
Response Package
Response package assembled: RP-020