About QC2

Auditing and Consulting Experience

Founded in 1996, QC2 has conducted 4,750 on-site and remote audits for 415 clients, ranging from small start-up 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.

QC2 has also supported more than 170 pharmaceutical/biotech companies, CROs, and investigator sites with standard operating procedure (SOP) review/gap analysis and preparation services, ranging in scope from specific department or function SOPs to full scale global SOPs. In addition, we have provided GCP, GLP, SOP, and/or QA training sessions at more than 70 pharmaceutical/biotech companies, CROs, and investigator sites.

Many of our audits can be conducted remotely, helping our clients to maintain their audit programs during this unprecedented time.

Global Expertise and Experience

QC2’s global experience is reflected in the 900+ audits we have conducted in 53 countries outside 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 of country-specific regulations and respectful of local cultures and working habits, which results in reliable and successful audits throughout the world.

QC2 Staff

The QC2 staff comprises six auditors and a two-person operations/project management team.

QC2’s auditors comprise an impressive team of knowledgeable and experienced auditors. With a combined 200+ years of experience in investigational product development, our auditors range between 21-54 years of industry experience each. Three of our staff have been with QC2 since its incorporation in 1996, and another four have been with QC2 for 14+ years each. QC2 auditors also have a comprehensive understanding of the industry stemming from their previous work experience in a variety of settings, including global pharmaceutical companies; clinical pathology, bioanalytical, and research laboratories; Phase I clinical research units; contract research organizations; and universities and medical centers

Auditors are assigned to audits and projects according to their specialties and expertise.

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. Further, QC2’s dedicated operations/project management team provides support to our auditors and clients with audit/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 to QC2. All staff train in QC2 SOPs and regulatory training relevant to their areas of expertise. QC2 can also work according to client SOPs and utilize client forms and templates.

Our staff participates in continuing education and professional development activities to maintain the high quality and standards of our services. QC2 staff stays abreast of the latest developments in the field. We also continuously monitor issuance of new or updated regulations, guidelines, and local requirements, and promptly incorporate changes into our processes.