Quality and Compliance Consulting, Inc. (QC2) offers global audit, SOP, training, and consulting services to the pharmaceutical, medical device, and biotechnology industries.
For 30 years, we have assisted clients in evaluating study conduct and compliance, establishing and maintaining quality systems, identifying practical solutions to quality and compliance challenges, and verifying patient safety and the validity and accuracy of study data.
Our range of services includes GCP audits, GLP audits, bioanalytical laboratory audits, central laboratory audits, CRO audits, vendor audits, sponsor audits, CSV audits, PV/safety audits, SOP review and development, training, and consulting.
Your company will benefit not only from our extensive experience and expertise, but also from the personalized attention we provide to each client and our commitment to delivering high-quality, cost-effective services.
Auditing and Consulting Experience
Founded in 1996, QC2 has conducted over 5,000 on-site and remote audits for 436 clients. These clients range from small start-ups to multinational pharmaceutical, medical device, and biotechnology companies, as well as contract research organizations, bioanalytical and toxicology laboratories, institutional review boards, university and private medical research centers, and investigator sites.
Additionally, QC2 has supported over 176 pharmaceutical/biotech companies, CROs, and investigator sites with standard operating procedure (SOP) review, gap analysis, and preparation services. These services can range from from specific department or function SOPs to full-scale global SOPs. Moreover, QC2 has provided GCP, GLP, SOP, and/or QA training sessions at more than 70 pharmaceutical/biotech companies, CROs, and investigator sites.
Global Expertise and Experience
QC2’s global experience is demonstrated through the 974 audits we have conducted in 53 countries outside of the US, including Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, and Uruguay.
In addition to expertise in FDA regulations and compliance programs and ICH guidelines, QC2 auditors are knowledgeable about country-specific regulations and respectful of local cultures and working habits. This approach ensures reliable and successful audits worldwide.
QC2 Staff
The QC2 staff consists of five auditors and a two-person operations/project management team.
QC2’s auditors are a highly skilled and experienced team and have a deep understanding of the industry due to their previous work in various settings, including global pharmaceutical companies; clinical pathology and research laboratories; Phase I clinical research units; contract research organizations; and universities and medical centers.
All of our auditors are dedicated full-time employees, guaranteeing uniformity and excellence across our clients’ audit projects. This commitment to consistency and quality ensures that every client receives the highest standard of service.
Teamwork and Support
QC2 maintains its high quality of audit and consulting services through a well-developed internal network of feedback, communication, and support. All audit reports are subject to extensive peer review to ensure accuracy and completeness, and QC2 auditors engage in regular and frequent communication about projects and audits. Furthermore, QC2’s dedicated operations and project management team provides support to our auditors and clients with audit and project planning, coordination, and logistics.
Maintaining Our Standards of Excellence
Building knowledge and skill sets and staying abreast of industry changes and trends are paramount at QC2. All staff are trained in QC2 SOPs and undergo regulatory training relevant to their areas of expertise. QC2 can also adhere to client SOPs and use client forms and templates.
Our staff actively participates in continuing education and professional development activities to uphold the high quality and standards of our services. At QC2, our staff stays up-to-date on the latest developments in the field. We continuously monitor the issuance of new or updated regulations, guidelines, and local requirements, and promptly integrate any changes into our processes.
