Case Studies

Our Cases

We supported a USA based ATMP manufacturer with a targetted review of their aseptic practices versus EU-GMP and revised Annex 1

We supported an International manufacturer with a review of their Data Integrity practices and controls across 3 sites globally.

We supported a China based sterile manufacturing site with a 6-month program for US-FDA Inspection Readiness

We supported a China based Biologics manufacturing site with a design review and consultation for a new facility build.

We supported a China based sterile manufacturer with a mock regulatory inspection for both EU and US requirements.

We supported a USA based manufacturer of a novel ATMP tissue product to advise on EU GMP compliance and product designation.

We supported a China based sterile manufacturing site with remediation for a US-FDA Warning Letter.

We supported an International manufacturer with the development and deployment of a comprehensive training program on aseptic practices