PBE Expert Inc, is a leading consulting pharmaceutical company involving a Health Canada Expert.
PBE Expert Inc, has successfully accomplished more than 80 projects involving Explosives & flammable products (ATEX, XP), (OEL6, BSL3) High Potent Compounds in compliance with related cGMP requirements from Health Canada, US-FDA, EMA, as well as North Africa regulations.
Sanitary design of process equipment, clean utilities, and pharmaceutical systems implies at the outset the conformity with the standard ASME-BPE and ISPE.
Design of Layouts is implemented through the control of clean environments (ISO-14644-4 and ISPE), by means of appropriate technologies ensuring high confidence in product integrity and quality, cGMP compliance and reducing cross contamination, Mix-Up, and critical gaps.
BPF | FDA | ANSM | Santé Canada | GCC | ISO14644 | ASME-BPE | ISPE | ICH Q9 | AMDEC | ATEX | NFPA | HSE |