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PAREXEL Consulting Alliance
Service Highlights
Integrated Expert Services:
Product Development and Regulatory Affairs
Clinical and Manufacturing Excellence
GxP Compliance and Risk Management
Clinical Process Optimization
Assessment and design or re-design of disparate or inefficient processes to optimize clinical development performance
Quality Systems Strategy, Design, Execution
Quality operational design or re-design, quality plan execution and documentation, quality training and monitoring
Manufacturing Scale-up
Expert services to enable timely production increases for market launch or increased product demand that integrates science, quality, and manufacturing processes to optimize product compliance and safety
Manufacturing Process Optimization
GMP performance management assessment, re-design, training, and implementation on single or across multi-plant operations
Due Diligence of Partners/Vendors/Aquisitions
Thorough evaluation of potential business relationships or transactions to provide realistic risk/benefit of ownership/transaction assessments
Post-merger Integration Services
Design, and and execution post-merger integration and process harmonization including skill assessments and training
Technology Adoption and Implementation Consulting
Integration of people, process, and technology to optimize performance impact of new technology to organizations on local or global scale, e.g., electronic submissions, regulatory document management, CTMS
