GxP, FDA, and EMA regulations require precise validation and traceability across all processes.
Translating lab-scale breakthroughs into reliable, compliant production pipelines.
Cold-chain monitoring for temperature-sensitive drugs, organs and biologics.
Leading and managing global CRO collaborations while ensuring data accuracy and regulatory readiness.
Hands-on experience with FDA, EMA, and GMP standards.
Onshore, offshore, or hybrid to match client needs.
Access to hard-to-find validation, QA, and process talent.
From lab equipment validation to IoT-driven supply chain monitoring.
Multi-year engagements with leading pharma and biotech firms.