Quality and Compliance Consulting, Inc.
Provider of audit, SOP, training, and consulting services for pharmaceutical, medical device, biotechnology, CROs, and clinical research sites. Services focus on GCP and GLP compliance, bioanalytical and central laboratory audits, computerized system validation, SOP systems, training, and regulatory inspection preparedness. Active globally since 1996.
Industries
Nr. of Employees
small (1-50)
Quality and Compliance Consulting, Inc.
Products
CAPA Management
Comprehensive consulting service for Corrective and Preventive Action (CAPA) management, root cause analysis, and effectiveness verification to ensure regulatory alignment and prevent repeat quality issues.
Regulatory Documentation & Technical Writing
Comprehensive regulatory documentation and technical writing services including SOPs, regulatory submissions, validation documentation, and audit-ready documentation packages.
Tailored Solutions
Custom compliance solutions, remediation programs, startup support, and integration and harmonization services tailored to specific organizational needs.
Deviation Investigation Services
Structured investigation discipline and support for deviations of all categories, from minor documentation discrepancies to critical product quality failures.
Workshops
Interactive sessions focused on building practical skills, including root cause analysis and audit readiness.
Inspection Readiness
Systematic assessment of facilities, documentation, and teams for FDA, EMA, and notified body inspections including mock inspections and gap assessments.
CAPA Management
Comprehensive consulting service for Corrective and Preventive Action (CAPA) management, root cause analysis, and effectiveness verification to ensure regulatory alignment and prevent repeat quality issues.
Regulatory Documentation & Technical Writing
Comprehensive regulatory documentation and technical writing services including SOPs, regulatory submissions, validation documentation, and audit-ready documentation packages.
Tailored Solutions
Custom compliance solutions, remediation programs, startup support, and integration and harmonization services tailored to specific organizational needs.
Deviation Investigation Services
Structured investigation discipline and support for deviations of all categories, from minor documentation discrepancies to critical product quality failures.
Workshops
Interactive sessions focused on building practical skills, including root cause analysis and audit readiness.
Inspection Readiness
Systematic assessment of facilities, documentation, and teams for FDA, EMA, and notified body inspections including mock inspections and gap assessments.
Services
On-site and remote audits covering investigator sites, Phase I facilities, toxicology studies, bioanalytical labs, central pathology labs, CROs, sponsors, and vendors; reporting and audit follow-up services.
Validation and compliance audits for clinical IT systems including EDC, safety databases, IVRS/IWRS/IXRS, ePRO, and LIMS, evaluating validation packages, testing, infrastructure, and 21 CFR Part 11 controls.
SOP gap analysis, SOP review and revision, and preparation of new SOPs and SOP frameworks aligned with regulatory requirements and industry best practices.
Customized on-site or remote training in GCP, GLP, 21 CFR Part 11/EU Annex 11, SOPs, and QA inspection preparedness for groups of varying size and skill level.
Consulting including audit plan development, site/vendor selection, audit scheduling, audit follow-up and CAPA review, mock regulatory inspections, and COA consulting.
On-site and remote audits covering investigator sites, Phase I facilities, toxicology studies, bioanalytical labs, central pathology labs, CROs, sponsors, and vendors; reporting and audit follow-up services.
Validation and compliance audits for clinical IT systems including EDC, safety databases, IVRS/IWRS/IXRS, ePRO, and LIMS, evaluating validation packages, testing, infrastructure, and 21 CFR Part 11 controls.
SOP gap analysis, SOP review and revision, and preparation of new SOPs and SOP frameworks aligned with regulatory requirements and industry best practices.
Customized on-site or remote training in GCP, GLP, 21 CFR Part 11/EU Annex 11, SOPs, and QA inspection preparedness for groups of varying size and skill level.
Consulting including audit plan development, site/vendor selection, audit scheduling, audit follow-up and CAPA review, mock regulatory inspections, and COA consulting.
Expertise Areas
- GCP compliance auditing
- GLP and nonclinical compliance auditing
- Bioanalytical method and laboratory auditing
- Central laboratory and clinical pathology auditing
Key Technologies
- Electronic Data Capture (EDC)
- Data management systems
- Safety databases
- IVRS / IWRS / IXRS
News & Updates
Founded in 1996 to provide audit, SOP, training, and consulting services to the pharmaceutical, medical device, and biotechnology industries.
Conducted 4,950 on-site and remote audits for 430 clients across a range of organizations including pharma, biotech, CROs, laboratories, IRBs, and investigator sites.
Completed 965 audits in 53 countries outside the United States.
Supported over 173 companies, CROs, and investigator sites with SOP review, gap analysis, and preparation services.
Delivered GCP, GLP, SOP, and QA training sessions at more than 70 companies, CROs, and investigator sites.
Founded in 1996 to provide audit, SOP, training, and consulting services to the pharmaceutical, medical device, and biotechnology industries.
Conducted 4,950 on-site and remote audits for 430 clients across a range of organizations including pharma, biotech, CROs, laboratories, IRBs, and investigator sites.
Completed 965 audits in 53 countries outside the United States.
Supported over 173 companies, CROs, and investigator sites with SOP review, gap analysis, and preparation services.
Delivered GCP, GLP, SOP, and QA training sessions at more than 70 companies, CROs, and investigator sites.