CASE STUDIES
Real GMP, GCP, PQS, QMS and ISO compliance projects delivered by QSN — from greenfield facility builds to phase-appropriate PQS implementations across pharma, biotech and medical device clients.
Greenfield ISO 13485 Medical Device Facility
Building a world-first process of its kind — and the ~200-document QMS behind it — from pilot through to ISO 13485 accreditation.
Phase-Appropriate QMS for a Clinical Biotech Sponsor
A right-sized GMP/GCP quality system, built and live in time for a sponsor's Phase 1 trial — without over-building for where they were.
PIC/S GMP for a Greenfield Cannabis Manufacturer
Setting up a full PQS and support for CMC, laboratory and transition to an eQMS — including Schedule 8 drug handling — ahead of the client's licensing inspections.
Advancing a Botanical-Derived Drug Product into Phase 2 Clinical Development
Turning a phase-appropriate PQS/DMS engagement into full Quality, CMC and regulatory support for a botanical-derived product's Phase 2 program.
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