PIC/S GMP Proficiency

PIC/S GMP

NPRA, Malaysia is one the earliest agencies to secured PIC/S membership in January 2002, well ahead of most of the emerging markets.
The NPRA issued PIC/S GMP license is well acknowledged by Ukraine, Thailand, Singapore, Taiwan, Hong Kong, Turkey, Argentina, Mexico etc.
Metina expedites product triggered GMP inspection through NPRA by application submission through Quest 3, support in screening deficiencies, fees payment and BE/CMC evaluation deficiencies response.
The service encompasses scientific writing of dossier in ACTD format, drug product classification and support till approval.
PIC/S GMP inspection service would cover submission of request letter, inspection dates finalization with inspection committee, preparing manufacturing site as per PIC/S GMP guide, CAPA submission till site licensing.
Metina also support BE/Clinical Center GCP inspection and approval through NPRA.
In addition, Metina offers Holding and Maintaining Marketing Authorisation with NPRA and Identifying importer / distributor post approval for product marketing.