GxP Audits
Our team of quality experts deliver thorough GxP audits and inspection readiness support tailored to your needs.
GXP AUDITSGxP Audit Services
Scendea’s GxP Audit services support clients with expert guidance to ensure compliance and prepare for regulatory inspections. Our global based team of ex-regulatory inspectors and senior quality professionals are located across Asia-Pacific, Europe and the United States and bring deep experience across the biotech and pharmaceutical landscape, providing flexible audit support at every stage of development. With auditors located locally, clients can avoid travel costs and delays while receiving flexible, tailored GxP audit and inspection readiness support that aligns with internal resources, timelines, and operational needs.
GxP Audit Programs
Scendea provides a full range of GxP audits, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GVP), across systems, studies and vendors. Whether conducted on-site or remotely, our audits are delivered by a team of ex-regulatory inspectors and quality experts who understand what regulators look for and how to assess and strengthen your compliance framework.
We work with clients to build audit programs, from vendor selection and in-process/study audits to reviewing issue resolution and providing quality support. We can also support standalone audits as needed, ensuring that critical processes and partners are thoroughly reviewed and aligned with regulatory requirements.
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Independent GLP Audits of Non-Clinical CROs (Global)
Scendea provides expert, independent GLP audits to assess compliance, ensure data integrity, and support regulatory readiness for non-clinical safety and toxicology studies.
Scope of Services
Pre-Audit Planning/Vendor Selection/Study Monitoring and Auditing/Issue Resolution
On-Site/Remote GLP Audit
Reporting & Recommendations
Follow Up Support
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Comprehensive GCP Audits of CROs, Vendors, Studies (Global)
Scendea provides global expertise in developing independent GCP audit programmes, identifying key risks and designing audit strategies that assess critical vendors, processes, study conduct, protocol compliance, data integrity, and participant safety, ensuring ongoing inspection readiness.
Scope of Services
Development of audit program including vendor qualification, in-study audits, and system audits
On-Site/Remote ICH E6(R3) GCP Audits (Vendors and Sites); first-in-human dosing audits
Reporting & Recommendations
Follow up Support
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CDMO Audits for GMP Compliance
Scendea provides GMP expertise from CDMO qualification audits through to ongoing GMP audits, ensuring your CDMO remains compliant with applicable GMP regulations. We also conduct mock inspection audits to support inspection readiness and provide targeted staff training.
Scope of Services:
Pre-Audit Planning/Vendor Selection/Study Monitoring and Auditing/Issue Resolution
On-Site/Remote GMP Audit
Reporting & Recommendations
Follow Up Support
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GVP Services are delivered by Scendea’s Pharmacovigilance Partner, Signal, providing clients with reliable, expert support in line with global regulatory requirements.
Inspection Readiness
If you are short on time, resources, or in-house experience, Scendea can help bring structure and focus to your inspection readiness activities. To help you take a proactive approach to regulatory inspections, our team conducts thorough mock inspections focusing on leadership engagement, clearly defined roles and responsibilities, quality management systems, and continuous improvement. These mock inspections serve as valuable training exercises, guiding targeted improvements to ensure your team is fully prepared and confident for a regulatory inspection.
Inspection Support & Issue Resolution
Scendea can provide on-site support during inspections, helping you manage daily regulatory requests, coordinate responses, and ensure smooth communication across your team. Our global presence means we are never far away and can support at short notice to meet your needs.
If observations or findings are issued, we support you in developing effective responses through root cause analysis, CAPA planning, and preparation of responses to Form 483s or other regulatory agency observations. We help ensure your response is both thorough and aligned with regulators’ expectations, supporting a strong post-inspection position.
Why Partner with Scendea?
Scendea’s Global GxP services are delivered by a trusted, international team of ex-regulatory inspectors and quality professionals, located across Asia-Pacific, Europe, the UK, and the USA. With deep experience in both biotech and pharma, we understand the practical challenges growing companies face and bring real-world insight to help meet regulatory expectations efficiently.
Whether you require a standalone audit, an ongoing program, or full inspection readiness and response support, we offer flexible, scalable models tailored to your needs.
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