Consulting Services
Quality Systems
We specialize in optimizing Quality Systems to ensure seamless compliance across the organization. Our services include monitoring and analyzing quality system metrics to identify gaps and drive continuous improvement initiatives. In addition, we develop comprehensive departmental training matrices that align employee skills with GMP and quality requirements, ensuring teams are well-prepared to meet regulatory expectations. We also bring expertise in electronic quality management systems, as a system administrator for ACE and Veeva QualityDocs, QMS, and RIM we provide practical, hands-on support in configuring, maintaining, and optimizing Veeva platforms to meet business and regulatory needs (passed Veeva Vault Associate Administrator exam July 2025)
Quality Consultant Services
We provide independent quality oversight across CDMOs and contract laboratories, ensuring strict regulatory compliance and operational excellence. Our expertise includes batch record and analytical data review to support the safe and compliant release of drug substances and drug products, as well as oversight of analytical technology transfers to accelerate timelines while maintaining regulatory integrity.
Our services include oversight for validation of phase-specific analytical QC test methods, facilitation of investigations with leadership in resolving deviations and compliance events, and comprehensive use of GMP-regulated quality management systems—including document control, change control, deviations, CAPAs, and DS/DP release.
Staff Training
At QOS Bio, quality system development means we train your staff on any quality system that is developed for your organization, in addition to offering Annual GMP Training.