Location: Long Duc IP, Long Thanh District, Dong Nai Province
Main scopes: Consulting
– GMP Training (12/2013)
– ISO 13485 Inspection support (12/2014 ~ 03/2015)
Authorities: BSI
Main scopes: Engineering (11/2017 ~ 10/2018 )
– Facility building:
– Design Review, Project Management
– Facility Validation/Qualification
Authorities: FDA
Main scopes: Engineering (12/2018 ~ 01/2020)
– Facility Building Expansion:
– Design review, project observation
– Facility Validation
Authorities FDA