COVALIGEN

About COVALIGEN

COVALIGEN is an advisory firm specializing in digital compliance, Computer System Validation (CSV), and Data Integrity for life sciences and regulated industries. With over 30 years of experience in GMP-regulated environments across France and Switzerland, our expertise covers Quality Control, Engineering, Qualification & Validation, Quality Assurance, and regulatory compliance. We support early-stage companies (pharmaceutical, biotech, emerging CDMOs, cosmetics,...) and organizations looking to modernize their approach to CSV, Data Integrity, and digital quality transformation — ensuring they are inspection-ready. We work with organizations facing challenges such as slow validation processes, data integrity observations, inspection pressure, and inefficient documentation frameworks. Our approach combines strategic advisory, readiness assessments, and agile methodologies to build compliant, efficient, and scalable systems — without replacing operational teams or CDMO partners. With European and international experience, we support companies entering EU and US markets by aligning with regulatory expectations and local practices. COVALIGEN stands for: Compliance, Validation, Intelligence, New Generation. Our services include : • CSV & Data Integrity strategic advisory • Compliance readiness and gap assessments • Agile validation and quality transformation • Digital quality and compliance framework structuring We also support sustainable change through human-centered approaches to strengthen leadership alignment and team dynamics (EQ-i 2.0). We offer tailored service packages (Diamond, Gold+, Silver, Standard) depending on your needs, see in our Service Overview (PDF) or on our website. A free initial consultation is available — feel free to reach out.