Posted Thu, 04 Apr 2024 08:16:29 GMT by Disha Dadke Associate President - Regulatory Affairs
The sponsor has submitted an MAA dossier to EMA for our product, BP02-Dazublys. During the process, a GCP inspection EMA/IN/0000173500 was announced for two investigator sites and the sponsor (CuraTeQ Bio) site in Hyderabad. However, as a sponsor, we are unable to find this request among the sites chosen for these inspections. We kindly request your assistance in resolving this issue as soon as possible.
Posted Tue, 07 May 2024 13:32:09 GMT by Paolo Tomasi EMA
The issue has now been addressed as part of the GCP procedure mentioned. Please note that Forum posts are intended for questions on general issues and applicants' discussions, and that no confidential information should be disclosed.
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