• Quality Review of regulatory documents from development to product launch.
• Regulatory and compliance risk management:
• Regulatory assessment on internal and external partners for cGMP compliance
• Regulatory inspection readiness
• Response to regulatory authority observations and comments
• Management of product information variations (artwork change management)
• Regulatory oversight of affiliates

• Provide Quality Project Experts
• Milestones, goals, project tasks, timetable, resources and team management
• Project Charter, project plan and tools to drive project to completion
• Workshops and Training on Project Management

• Review company quality processes
• Assess company compliance status
• Provide risk analysis report
• Define mitigation strategy

• Quality by Design
• Design of product and manufacturing process control strategy
• Management of real time release testing and design space management
• Design and creation of quality target profile (QTTP)
• Procedures to monitor critical process parameters
• Development of documentation GMP compliant
• Define level of GMP required at each phase of the drug development phase

• Development of validation strategy (family approach for equipments and processes)
• Development of site validation plans
• Perform quality risk assessment for critical operations
• Review of facility, equipments, SUBs and test methods validation documentations including design documentations, IOQ and PV protocols and reports for water systems, media tanks, bioreactors, HVAC, gasses, compressed air etc)
• Design sampling strategy for confidence and bridging sampling for utilities
• Development of tools to monitor validation activities (example tracking tools, matrix, SOPs, templates etc, etc)
• Review and approval computer system documentation according to GAMP 5 from design to PQ (example PIMS Tags, Automation risk assessments etc, etc)
• Review, approval and implementation of validation project changes
• Coordination of subcontractors activities in validation projects (including review and approval of contractor documentations)
• Generate and manage cleaning validation strategies (manual vs CIP/SIP)

• Design and manage technology transfer strategy
• Design procedures for analytical method transfer
• Review of qualification documentations during technology transfer
• Review and approve changes during tech transfer
• Review and approve deviations and OOS during tech transfer
• Investigate OOS and deviations during tech transfers
• Development and implementation of stability product strategy
• Develop and implement stability program
• Development of specifications
• Periodic review of stability data including data trending and analysis
• Optimisation of stability program

• Strategy for selection of suppliers
• Outsourcing strategy for GMP compliance
• Identify and create procedures for the external vendors
• Quality management
• Monitor cooperation of partners during the manufacturing process
• Identify areas for improvement during manufacturing
• Interface between companies for successful project management