GMP inspection findings clarification
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0019. Type: query. Risk: high. Category: Quality.
Correspondence ID
COR-419
Type
query
Application
Authority
Ministry of Health of Russia
Category
Quality
Risk
High
Due Date
2025-03-23
Status
Open
Owner
Nadia Petrova
Created
2023-12-07
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0019, 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
attachment_419_1.pdfstudy_report_419.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.