The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
Gafchromic films support patient care in oncology
The company is addressing these observations
The observations are procedural in nature
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
None of the observations are related to data integrity and management believes that they are addressable
The company had responded to the agency and carried out the required corrective actions.
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
The company will address the observations within a stipulated timeline working with the regulators
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