- Compilation, preparation & review of dossiers in CTD, ACTD formats and country specific as per regulatory guidelines of countries.
- Active Co-ordination with Inter department (Production, Quality Assurance, Quality Control, Packaging department and F & D) for technical data requirement.
- Knowledge/Exposure of ICH Guidelines (QSEM) required for Common Technical Document (CTD) for the registration of pharmaceuticals for human use.
- Preparation and review of SmPC, Package insert and labeling information.
- Knowledge and file online application for dossier submission in US.
- Handling of query as per received from client & MOH.
Ahmedabad, Gujarat, India
Acme Generics
Acme Generics
JS2868747380
22/12/2024 4:02:43 AM
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