Information request: extractables and leachables data
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0079. Type: information-request. Risk: medium. Category: Quality.
Correspondence ID
COR-179
Type
information-request
Application
Authority
Ministry of Health of Russia
Category
Quality
Risk
Medium
Due Date
2025-03-04
Status
Overdue
Owner
Carlos Mendez
Created
2023-12-20
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0079, 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_179.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.