About Quality and compliance consulting, inc.
Quality and Compliance Consulting, Inc. is a leading consulting firm that specializes in providing quality assurance and compliance services to the life sciences industry. With over 20 years of experience, the company has established itself as a trusted partner for pharmaceutical, biotech, medical device, and clinical research organizations.
The company offers a wide range of audit services including GCP audits, GLP audits, bioanalytical laboratory audits, vendor audits, CRO audits, sponsor audits, CSV audits and central laboratory audits. These services are designed to help clients ensure compliance with regulatory requirements and industry standards.
GCP Audits: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing conducting recording and reporting trials that involve human subjects. Quality and Compliance Consulting provides GCP audit services to ensure that clinical trials are conducted in accordance with applicable regulations such as ICH-GCP guidelines.
GLP Audits: Good Laboratory Practice (GLP) is a set of principles intended to assure the quality of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. Quality and Compliance Consulting provides GLP audit services to ensure that non-clinical studies comply with applicable regulations such as OECD guidelines.
Bioanalytical Laboratory Audits: Bioanalytical laboratories play an important role in drug development by analyzing biological samples from clinical trials. Quality and Compliance Consulting provides bioanalytical laboratory audit services to ensure that these laboratories comply with applicable regulations such as FDA guidance documents.
Vendor Audits: Vendors play an important role in supporting the operations of life sciences companies by providing goods or services such as raw materials or contract manufacturing. Quality and Compliance Consulting provides vendor audit services to ensure that vendors meet client requirements for quality assurance.
CRO Audits: Contract Research Organizations (CROs) provide support for clinical trial activities such as study design data management statistical analysis etcetera on behalf of sponsors who are responsible for the conduct of clinical trials. Quality and Compliance Consulting provides CRO audit services to ensure that CROs comply with applicable regulations such as ICH-GCP guidelines.
Sponsor Audits: Sponsors are responsible for the conduct of clinical trials and must ensure that all aspects of the trial are conducted in accordance with applicable regulations such as ICH-GCP guidelines. Quality and Compliance Consulting provides sponsor audit services to ensure that sponsors meet their regulatory obligations.
CSV Audits: Computer System Validation (CSV) is a process used to ensure that computer systems used in regulated activities operate in a consistent reliable and accurate manner. Quality and Compliance Consulting provides CSV audit services to ensure that computer systems comply with applicable regulations such as FDA guidance documents.
Central Laboratory Audits: Central laboratories play an important role in supporting clinical trials by analyzing biological samples from multiple sites. Quality and Compliance Consulting provides central laboratory audit services to ensure that these laboratories comply with applicable regulations such as FDA guidance documents.
In conclusion, Quality and Compliance Consulting, Inc. is a trusted partner for life sciences companies seeking quality assurance and compliance consulting services. With its extensive experience, the company offers a wide range of audit services designed to help clients achieve compliance with regulatory requirements while maintaining high standards of quality assurance. Whether it's GCP audits, GLP audits, bioanalytical laboratory audits or any other type of audit service, clients can rely on Quality and Compliance Consulting for expert advice tailored to their specific needs.