GCP and GMP Compliance Audits
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Stridon performs GCP and GMP compliance audits on behalf of the pharmaceutical industry, biotech companies, CROs and academic institutions. Available internationally through a network of experienced professionals, we offer our clients:
We perform independent audits of clinical trial sites and IMP contract manufacturers. Our clinical trial and site audits are designed and timed in such a way that any potential regulatory non-compliance with the high ethical, GCP and GMP standards is identified at an early stage, before it becomes an issue affecting the regulatory acceptability of your clinical trial. To this end, we also offer:
Our consultancy in this area includes review, gap analysis and development of your Quality Management Systems or those of the clinical trial site.
Inspection readiness programmes as standard comprise of an initial inspection readiness assessment at the site, including a mock inspection, reporting deficiencies and actions to address these, working closely with the organisation in assigning roles and responsibilities in preparation for the upcoming inspection, monitoring progress against timelines and providing training for the site’s staff so they are ready to interact with regulatory inspectors competently and with confidence.