Quality and Compliance Consulting, Inc. (QC2) provides worldwide audit and consulting services to the pharmaceutical, medical device, and biotechnology industries.
Our expert staff will help you find practical solutions for regulatory compliance issues, develop and maintain quality systems, and ensure the validity and accuracy of your study data. In addition, our audits will assist you in assessing the adequacy of study conduct and compliance with FDA regulations and guidelines, ICH GCPs, local and international regulations, protocols, and SOPs.
Founded in 1996, QC2 has conducted over 2,400 audits in 44 countries, including the United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Latvia, Mexico, Netherlands, Panama, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and the United Kingdom.
Our 200+ clients have ranged from small start-up to multinational pharmaceutical, medical device, and biotechnology companies, contract research organizations, bioanalytical and toxicology laboratories, institutional review boards, university and private medical research centers, and investigators.
Your company will benefit not only from our experience and expertise but also from the personal attention we give to each project and our dedication to providing high quality, cost-effective services.
QC2 offers a broad range of audit, SOP, training, and consulting services which are customized for your specific needs. Our services include:
- Investigator Site Audits
- Phase I Facility and Study Audits
- Institutional Review Board (IRB) Audits
- Essential Documents/Trial Master File (TMF) Audits
- Electronic Trial Master File (eTMF) Audits
- Data Listing Audits
- Clinical Study Report (CSR) Audits
- Toxicology Facility and Study Audits
- Formulation Analysis and Bioanalysis
- Pathology Evaluations including Contracted Reading Vendors
BioAnalytical Laboratory Audits (GCP and GLP)
- Large and Small Molecules
Clinical Pathology Laboratory Audits
- Safety Panels
- Flow Cytometry
- Cell-Based Assays
- Specialty Diagnostics
Sponsor Audits, CRO Audits, and Vendor Audits
- Clinical Operations Audits
- Data Management and Biostatistics Audits
- IVRS Audits and IWRS Audits
- Central Reading Center Audits
- Electronic Data Capture (EDC) and Remote Data Capture (RDC) Audits
- Site Management Organizations (SMO) Audits
- Safety Reporting Audits
Computerized System Validation (CSV) Audits
- Data Management Systems including Electronic Data Capture (EDC)
- Safety Databases
- IVRS and IWRS
- Electronic Patient Reported Outcomes Devices (ePROs)
- Laboratory Information Management Systems (LIMS)
- QC Laboratory Audits
- Investigational Product Packaging and Labeling Facility Audits
- Depot and Distribution Audits
Standard Operating Procedures (SOPs)
- SOP Gap Analysis
- SOP Review and Revision
- SOP Preparation
- GCP Training
- GLP Training
- SOP Training
- QA Training
- Audit Plan Development
- Audit Follow-Up and Review of Corrective Actions
- Preparation for FDA Inspections and Mock FDA Inspections
- Patient Reported Outcomes (PRO) Consulting
QC2 audits are customized for your specific project and budget needs. We can provide assistance with all aspects of your audits projects, including audit plan consulting and development; scheduling, conducting, and reporting on audits; and providing audit follow-up services, including review of audit responses. We can conduct both general qualification audits and in-study audits. Please contact us for more information about how QC2 can help meet your needs.
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