BSSI has established standard operating procedures (SOPs) and quality assurance / quality control (QA/QC) policies in accordance with ICH guidelines. These procedures and policies have been officially reviewed and approved in all prior industry quality control assessments. We welcome clients to review our SOPs and QA/QC policies.

Compliances

• Our electronic records and clinical databases are all 21 CFR part 11 – FDA compliant.
• Pharmacogenomic / Pharmacogenetic analyses on clinical trials are conducted in accordance with ICH expectations.
• U.S. Safe Harbor Privacy Principles (view PDF)

More information is available on the services we offer to meet your needs:

• Analyzing Biomarkers
• Drugs and Biologics
• Medical Devices