Our laboratory teams stay abreast with the latest regulatory requirements, guidance, and industry expectations. We continually optimize study workflows to maximize efficiency with desired compliance.
Our scientists fully validate bioanalytical methods for your studies and thoroughly assess analyte stability. Sample integrity is the most important aspect of the process and we monitor full chain of custody for sample storage conditions. We conduct end-to-end experimentation and report summary results according to our Standard Operating Procedures (SOPs). Our dedicated Quality Assurance Unit carefully ensures strict compliance with the SOPs and regulatory requirements.
Our audit history with regulatory authorities and client inspections is spotless, with the most recent FDA audit completed successfully as early as 2016. All our employees are routinely trained in regulatory compliance (FDA: GLP, GCP), safety (CDC, OSHA), waste management (EPA), patient privacy (HIPAA), HR focused policies, and additional areas as needed.
In our experience, this continual emphasis on the highest quality translates to reliable and reproducible bioanalytical data for our clients.