Quality System Design

·        An integrated approach including assessment of current quality systems, assistance in developing long and short-term quality objectives, including regulatory compliance or accreditation preparedness, critical path analysis and ultimate system design.

Quality Assurance Services

·        Protocol Review

·        Critical Phase Inspections

·        Facility Inspection

·        Process-based Inspections

·        Final Report and Raw Data Inspection

Quality Control Services

·        QC System Design and/or Assessment

·        Method Validation Preparation

·        Data verification, calculations and assessment for compliance

Technical Writing

·        Standard Operating Procedures

·        Methods

·        Protocols

·        Reports

·        Quality Manual

·        Data Collection Form Design