Quality and compliance

The paperwork is the product too.

A raw material supplier in medical biotech sells two things: the material and the confidence to file it. Both ship together.

COA · TRC · TSE · END

Certifications and quality systems

Certificate

ISO 13485ISSUED — · PENDING

Certificate

GMP statusISSUED — · PENDING

Certificate

Master file arrangementsISSUED — · PENDING

Certificate

AdditionalISSUED — · PENDING

Pending: certifications held or in progress, with issue dates

COACertificate of analysis

TRCTraceability record

TSETSE and BSE statement

ENDEndotoxin data

Pending: additional documents per founder

Released with its file

COA · TRC · TSE · END

Final checking and release for Western distribution runs through Alpstein’s Swiss operation.

Pending: word to whatever the founder confirms Switzerland actually does

The closed system was built to be inspected, and the strongest thing we can show a quality team is the line itself.

Pending: keep only if the founder will honour the invitation