Quality Assurance Consultancy supports organizations in conducting clinical studies for
regulatory compliance.
Serving as third-party quality assurance (QA) auditors under the U.S. Food and Drug Administration (FDA)/International Conference on Harmonisation (ICH) GCP, our specialists serve as the independent review of clinical studies to improve the quality of the reports you submit to the FDA.
We operate on behalf of the sponsor, or the clinical research organization (CRO), providing the following services:
CRO/site qualification
Case report form (CRF) development and design
Investigators brochure (IB) audit
Investigational new drug (IND) submission review
Institutional review board (IRB) audit
Source documents review
Database audit
Bioanalytical data and report audits
Trial master file review
Clinical reports audits
New drug application (NDA) submission review
We also operate on behalf of individual clinical sites, offering the following services:
