Our auditors have a broad range and depth of experience and can support a variety of audits including pre-clinical to clinical investigative (CROs), material suppliers, distribution and logistics firms, contract service organizations (CMOs, CDMO, etc.), as well as internal audits. Many of our auditors are certified by ASQ or other recognized certification bodies should your audit, either local or international, require a certified auditor.
Our auditors use a standard process for planning and conducting audits that provide our clients with the needed assurance that vendors, systems, or processes have been rigorously vetted for compliance to applicable regulations and customer requirements. Whether your focus is GLP, GDP, GMP, GCP or GVP, our seasoned auditors deliver audit reports tailored to your needs.
We provide audits across the spectrum of GxP businesses assisting clients at all stages of development, from pre-clinical through post-market approval.
Typical audits that we specialize in include:
Understanding where and how to implement risk management is critical to business success. Our team of quality and technical professionals have a strong understanding of the principles of ICH Q8, Q9 and Q10 and have used this experience and expertise to create and integrate QRM programs across the product lifecycle.
Specific Quality Risk Management (QRM) services include:
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
22320 Foothill Blvd. Suite 330, Hayward CA 94541