Services
Looking for GCP expertise to strengthen compliance across your clinical activities? ObelysQ acts as your trusted GCP Quality Assurance partner, providing senior-level expertise to support clinical programs at every stage—from early development through late-phase trials and inspection readiness.
We have conducted hundreds of audits worldwide across a broad range of therapeutic areas and development stages. Our auditors are seasoned quality professionals with hands-on regulatory and operational experience, deliver best-in-class audits.
Do you need set-up your QMS or update some SOPs in preparation for the start of your clinical program? ObelysQ will help you develop a lean quality management system that will allow you to remain agile. Together we will ensure that your business model and company culture is integrated in your procedural framework.
ObelysQ supports biotech, Pharmas, CROs, and clinical sites through all phases of Health Authority inspections, including EMA, FDA, and national competent authority inspections. From early inspection readiness assessments to on-site inspection management and post-inspection remediation, we provide hands-on, senior-level support to ensure confidence, control, and successful outcomes.
Is your team aware of latest regulatory/compliance trends? ObelysQ can host regulatory training sessions to ensure that your team is aware of the latest updates using examples and case scenarios based on their function and company structure.
ObelysQ conducts structured, risk-based GxP gap analyses to assess the robustness and regulatory alignment of Quality Management Systems (QMS). Our assessments provide clear visibility of compliance gaps, operational risks, and pragmatic remediation pathways aligned with regulatory expectations and business objectives.
ObelysQ provides specialized data protection support tailored to clinical research and regulated life-sciences activities. Our services include GDPR-aligned data protection gap analyses, acting as an external Data Protection Officer (DPO), and serving as an external EU data representative. We help organizations protect personal data, demonstrate regulatory compliance, and maintain trust with regulators, partners, and trial participants.
