GMP Audits & Mock Inspections
Comprehensive audits tailored to identify potential gaps in GMP systems and proactively improve site readiness for regulatory inspections.
Services
Specialized consulting for regulated manufacturers
From inspection readiness to Quality Systems optimization. Personalized and clear recommendations based on data analysis and compliance health assessments, with a competitive and accessible cost structure tailored to project complexity.
Services
GMP Compliance Services
End-to-end programs to ensure regulatory readiness and ongoing compliance.
Compliance Remediation Plans
Development of remediation plans and targeted corrective action plans to address and close compliance gaps.
Regulatory Inspection Readiness
End-to-end preparation programs for upcoming regulatory inspections.
Services
Laboratory Excellence Services
Optimize end to end laboratory operations from sample receipt to test results disposition.
Laboratory Technology Implementation
Selection, qualification and rollout of analytical technologies and LIMS systems.
Laboratory Process Optimization
Streamlining workflows to improve laboratory throughput with an increased regulatory mindset.
Laboratory Investigation Process Support
Assessment and support for improvement of process and laboratory investigations related to atypical or OOS results, unknown peaks, atypical trends, etc., including related CAPAs and CAPA effectiveness.
SOP and WI Assessment and Development
Assessment of laboratory systems in place to recommend the implementation of robust SOPs and processes from a compliance and efficiency perspective.
Instrument Validation Lifecycle
IQ/OQ/PQ programs and ongoing qualification management.
Services
Quality Systems Consulting
Build and scale the quality organization, processes and people that drive excellence.
Site Quality Systems Improvements
Assessment of organization Quality systems to identify and develop robust improvements.
Quality Department Design
Org design and role definition for high-performance teams.
Coaching & Mentoring
Senior advisory support for quality leaders and teams.
GxP Training Programs
Tailored training curricula for GMP, GLP and GDP compliance.
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