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 their study data. In addition, our audits will assist you in assessing the adequacy of site, vendor, and sponsor study conduct and compliance with FDA regulations and guidelines, ICH GCPs, local and international regulations, protocol, and SOPs.

Since 1996, we have conducted more than 1,500 audits in 33 countries, including in the United States, Argentina, Australia, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Japan, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, and the United Kingdom.

Our clients include 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.

qc²provides the following services:

GCP, GLP, and BioAnalytical Audits

• Investigative Sites (In-Study or Pre-FDA Inspection)
• Phase I Units and PK/PD Studies
• Institutional Review Boards
• Clinical Trial Files -- Essential Documents

• Clinical Trial Data Listings
• Clinical Trial Reports, ISSs, and ISEs

• Toxicology Laboratories and Studies
• BioAnalytical Laboratories, Method Validation, and Assays

Sponsor, CRO, and Vendor Audits (Qualification or In-Study)

• Clinical Data Management and Project Management Systems
• Computer System Validation and 21 CFR Part 11 Compliance
• Electronic Data Capture
• Data Management Systems and Biostatistics

• Clinical Operations and Project Management Systems
• Medical Writing
• Regulatory Affairs
• Safety Systems and Medical Monitoring

• Interactive Voice Response Systems
• Central Reading Facilities (ECG, Radiology, etc.)
• Clinical Pathology Laboratories and Esoteric Testing
• Investigational Product Packaging, Labeling, and Distribution

• Due Diligence Audits

Standard Operating Procedures

• Gap Analysis of Existing SOPs
• Revision of Existing SOPs
• Preparation of New SOPS

Training and Customized Workshops

• GCPs and GLPs
• Standard Operating Procedures
• Quality Assurance

Consulting

• Audit Plan Development
• Audit Follow-Up and Review of Corrective Actions
• Preparation for FDA Inspections, and Mock FDA Audits

Contact Information

Quality and Compliance Consulting, Inc

123 Carbonera Drive
Santa Cruz, CA 95060 USA
Phone: 831-466-9101
Fax: 831-515-5072
E-mail:

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