Health Authority inspections are high-stakes events that require experience, structure, and real-time decision-making. ObelysQ provides end-to-end inspection support grounded in deep regulatory expertise and practical field experience. Our teams prepare organizations, vendors, and investigator sites to meet inspection expectations, support sponsors and sites during inspections, and drive effective post-inspection remediation. Clients value our calm, authoritative presence, our ability to anticipate inspector focus areas, and our clear, pragmatic guidance under pressure.
Facing multiple Health Authority inspections across regions, we needed experienced professionals who could step in immediately and represent us with confidence. ObelysQ provided hands-on support at the sites, clear communication with inspectors, and strong coordination with our internal teams. Their involvement was critical to our inspection success.
Head of Clinical Quality, US Biotech
When an inspection is announced, ObelysQ acts as a central coordination and control point, bringing structure, clarity, and discipline to what is often a highly stressful process. We rapidly assess inspection scope and risks, define a clear inspection strategy, and establish roles, communication pathways, and document readiness plans. During the inspection, we support sponsors, CROs, and sites in real time—preparing interviewees, managing document requests, tracking inspector questions, and ensuring consistent, accurate responses. Our teams act as confident sponsor or site representatives when needed, facilitating interactions with inspectors while protecting the organization from unnecessary exposure. Following the inspection, we lead or support root cause analysis, response drafting, and CAPA implementation to ensure findings are addressed effectively and sustainably. The result is a controlled inspection process, aligned messaging, and outcomes that stand up to regulatory scrutiny.
Case Study
Overview: A fast-growing biotech preparing for its first regulatory submission faced significant pressure to ensure that its clinical trial data, investigator sites, and sponsor processes were inspection-ready. With limited internal QA resources and aggressive timelines, the company engaged ObelysQ to conduct pre-inspection visits and compliance assessments.
Challenge: The pivotal study was operationally complex, involving a large number of investigator sites and trial participants. The sponsor lacked prior inspection experience and needed rapid, structured insight into its true compliance risks.
Results: ObelysQ deployed an experienced audit team and conducted a series of 10 targeted pre-inspection visits. Key compliance risks were identified, prioritized, and translated into actionable and pragmatic remediation plans. ObelysQ supported CAPA development and implementation. Within four months, the company successfully passed an EMA inspection with no critical findings, enabling regulatory submission with confidence.
Overview: A US-based biotech was notified by both the FDA of six investigator site inspections to be conducted over a four-month period across the USA, Latin America, and Europe.
Challenge: The sponsor lacked the internal resources to prepare multiple sites in parallel, ensure consistent inspection readiness, and maintain sponsor presence during each inspection—particularly across different languages and regulatory cultures.
Results: Immediately upon engagement, ObelysQ deployed a coordinated team of senior auditors fluent in Spanish, German, English, and Polish, operating under centralized oversight by an ObelysQ inspection lead. Sites were rapidly prepared, key risks were identified, and remediation actions were implemented. ObelysQ acted as the sponsor representative during inspections, supporting site staff, managing inspector interactions, and maintaining real-time communication with the sponsor. The inspections concluded with no FDA Form 483s.
Overview: A small Swiss biotech conducting its first clinical trial was notified of an upcoming Swissmedic inspection. The company operated with a lean structure and had no internal Quality Assurance function, relying primarily on external partners for clinical operations.
Challenge: The sponsor had limited inspection experience and no dedicated QA resources to prepare internally, coordinate with investigator sites, or manage inspection logistics. Key risks included:
- Inconsistent documentation across sponsor and vendor records
- Limited oversight evidence of CRO and site activities
- Uncertainty regarding Swissmedic inspection expectations and interview conduct
- With a short notice period (one month), the company needed immediate, hands-on support to ensure inspection readiness and effective representation.
Results: ObelysQ was rapidly engaged and acted as the QA and inspection lead for the sponsor. Our team conducted focused inspection readiness assessments of sponsor documentation and key vendors, prepared inspection binders, and coached sponsor staff and investigator sites. ObelysQ supported the sponsor during the inspection as the primary quality contact, managing inspector interactions, facilitating document requests, and ensuring clear, consistent communication. The Swissmedic inspection concluded with no critical findings.
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