We help biopharma manufacturers and CDMOs solve complex Good Manufacturing Practices and Quality challenges.
Explore how we help biopharma companies simplify compliance, eliminate sterility risks, and optimize production systems.
Control contamination risks and ensure Annex 1 compliance — from Contamination Control Strategy (CCS) and risk-based Contamination Control Risk Assessment to environmental monitoring, aseptic behaviour, and quality oversight.
We help you supervise, evaluate, and recover control over your CDMOs and critical suppliers — before quality issues threaten your supply chain or regulatory compliance.
Prepare your sites for FDA, EMA, and Swissmedic inspections — including mock audits, formal FDA meeting support, and remediation after 483s or warning letters.
Simplify first — then harmonize. We help you reduce complexity and standardize your Quality Systems across sites, creating lean, scalable processes that actually work in daily operations.
Optimize your aseptic production processes — improving line performance, reducing contamination risks, and supporting your teams where production meets GMP.