PBE Expert Inc, is a consulting company in the biotech industries sector involving a Health Canada Expert.
PBE Expert Inc, has successfully completed several projects involving explosive products (ATEX), confined (BSL3) and comply with the regulatory requirements BPF / cGMP in Canada, USA (FDA), Europe (ANSM), as well as North Africa regulations.
PBE Expert Inc provides the biotech and bioprocessing (BSL3 containment) industry with skilled resources, in process engineering, layout, validation, calibration, maintenance, quality assurance and regulatory compliance.
The design of bioprocesses, clean utilities, and containment systems (BSL3) implies from the beginning compliance with ASME-BPE and ISPE standards.
The containment layout design BSL3 also involves the control of clean environments (ISO-14644-4 and ISPE), cross-contamination prevention technologies, BSL3 risks and Mix-Up crossings, break-downs integrity, consistency and conformity.
BPF | FDA | ANSM | Santé Canada | GCC | ISO14644 | ASME-BPE | ISPE | ICH Q9 | AMDEC | ATEX | NFPA | HSE |