Services

Consulting, quality management, and regulatory expertise for pharma, biotech, and medtech.

Hands-on support – without the detour

We take ownership where quality, compliance, and time pressure converge. You get senior profiles who work alongside your team – not slide producers.

Operational support for quality, compliance, and inspections.

We take over your quality management on a temporary basis – pragmatic, results-driven, with full responsibility for ongoing compliance.

Pre- and post-inspection preparation, working off backlogs in QTA, APQR, deviations, or change control.

Plan, run, and follow up on audits. We close QMS gaps before they turn into findings.

IQ, OQ, PQ, and PPQ from a single source. Facilities and processes that hold up to the next inspection.

Design and deployment of a robust quality management system – regulatory-clean, workable in daily operations, scalable with your business.

Transition to electronic quality processes: migration of existing content, platform validation, and a secure data architecture.

When strategy meets day-to-day delivery.

Continuous quality oversight with a dedicated point of contact. We stay engaged so you stay inspection-ready.

From licence to released process. We build your life science operation in a structured way so you can focus on value creation.

Process relocation between sites or partners. Knowledge is preserved, regulatory requirements are met, supply continuity is maintained.

Complex programmes run with structure – teams, timelines, and deliverables coordinated, budget and compliance under control.

We hold the wholesale and distribution authorisations required in Austria.

Pharmaceutical Wholesale

Medical Device Trade

Wholesale of Poisons

We assess at no cost whether our profile fits your project – and tell you straight away if it does not.