Information request: extractables and leachables data
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0099. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-499
Type
query
Application
Authority
Ministry of Health of Russia
Category
Administrative
Risk
Medium
Due Date
2025-03-15
Status
Draft
Owner
Priya Sharma
Created
2023-06-05
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0099, 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
Attachments
study_report_499.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.