About QC2

Auditing and Consulting Experience

Founded in 1996, QC2 has conducted 3,700+ audits for 325 clients, ranging from small start-up to multinational pharmaceutical, medical device, and biotechnology companies.  QC2 clients have also included 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 100 pharmaceutical/biotech companies, CROs, and investigator sites with standard operating procedure (SOP) review and/or gap analysis services, ranging in scope from specific departments or functions to full scale global, cross-functional assessments.  We have also provided SOP preparation services for more than 40 pharmaceutical/biotech companies and CROs.  In addition, we have provided GCP, GLP, SOP, and/or QA training sessions at more than 60 pharmaceutical/biotech companies, CROs, and investigator sites.

Global Expertise and Experience

QC2’s global experience is reflected in the 760+ audits we have conducted in 50 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, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, and Uruguay.

Audits are performed to assess compliance to applicable regulations while respecting the local culture and working habits.  Our approach results in reliable, successful audits and follow-up throughout the world.

QC2 Staff

The QC2 staff is comprised of seven full-time consultants and a two-member project management team.  Our highly skilled staff is committed to helping meet your audit needs.  Consultants are assigned to audits and projects according to their specialty and expertise.

QC2’s seven consultants comprise an impressive team of knowledgeable and experienced auditors.  With a combined 230+ years of experience in investigational product development, our consultants range between 18-50 years of industry experience each.  Four of our staff have been with QC2 since its incorporation in 1996, and another four have been with QC2 for 10+ years each.  QC2 consultants 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
  • Universities and medical centers

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 consultants engage in regular and frequent communication about projects and audits.  Further, QC2’s dedicated project management team provides assistance with 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.