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 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 1,800 audits in 37 countries, including the United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Japan, Mexico, Netherlands, Panama, Peru, Philippines, Poland, Puerto Rico, Romania, 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.
GCP, GLP, and BioAnalytical Audits
Sponsor, CRO, and Vendor Audits (Qualification or In-Study)
Standard Operating Procedures
Training and Customized Workshops
Consulting
Worldwide Audit and Consulting Services
