Device-assembly enquiries
Device-related enquiries to GALVANTA COMPANY LIMITED should distinguish the medicine, container, delivery device and organisations responsible for each element.
Device format
Identify the proposed format and intended regulatory context, distinguishing a pen or cartridge description from the pharmaceutical formulation and an authorised combined presentation.
Components
Specify the component information relevant to the enquiry and the party controlling the specifications, using evidence of supplier approval and component qualification separate from any website image.
Cartridge interfaces
Describe the relationship between the container and delivery mechanism and the evidence for compatibility, delivered quantity and performance.
Assembly scope
State the proposed activities and responsible organisation, identifying any assembly obligations separate from those applying to the medicine or individual component.
Examination and performance
Identify the mechanical or functional questions to be addressed and the separate evidence of completed testing and conformity to the relevant standard.
Documentation
Specify the component references, specifications, assembly records or other documents requested.
Contact
Email [email protected], identifying the device, relevant medicine presentation, country and purpose of the enquiry.
Do not send used devices or patient information through the initial route.
Prerequisites
The company holds no pharmaceutical manufacturing licence or GMP certificate. Any proposed work depends on evidenced capability, applicable authorisations and a separate agreement. Device-assembly capability and device approval require separate evidence. The website provides no certification, validation result or release decision for a device.