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Our service specializes in the implementation and enhancement of Quality Systems within the pharmaceutical market. We offer comprehensive landscape implementation and/or improvement for all quality activities, including Standard Operating Procedures (SOPs), batch record review, training programs, effective Change Control, and Deviation management, ensuring regulatory compliance and product quality
We assist in designing and implementing a comprehensive Quality Management System (QMS) tailored to your organization’s needs, ensuring alignment with regulatory requirements and industry best practices. Additionally, we are able to implement the perfect Management Review process, considering the reality of your company.
Our consultants perform a comprehensive GAP Assessment of your Quality management practices, scrutinizing SOPs, processes, and systems. We meticulously compare these practices against regulatory standards from authorities like the FDA and EMA, identifying potential GAPs.
Based on our findings, we provide detailed reports outlining identified GAPs and deficiencies, along with actionable improvement. recommendations for improvement.
Our goal is to ensure that your Quality management system is robust, compliant, and continuously improving to meet the evolving regulatory landscape and industry standards.
We offer a comprehensive Audit Readiness Program to prepare your organization for regulatory inspections, including training, GAP Assessments, documentation review, and mock inspections, to ensure readiness and compliance. Our Mock Inspection service simulates real regulatory inspections, providing valuable practice for your team, identifying potential gaps or deficiencies, and offering recommendations for improvement to ensure readiness for official inspections.
Digital Solutions (Computerized Systems) – Implementation and Improvements
Digital Solutions (Computerized Systems) – Routine Support
Qualification and Validation – Implementation and Improvement
Computerized Systems Validation Landscape – Implementation or Improvement
Master Data Management (Computerized Systems) – Strategic Consultancy
Access Management (Computerized Systems) – Strategic Consultancy
Implementation of a new Computerized System – Strategic Consultancy
Computerized Systems Validation Audit Readiness – Strategic Consultancy
Computerized Systems Validation Audit Readiness – Routine Support
Quality Management Systems Landscape – Implementation or Improvement
Quality Management Systems Audit Readiness – Strategic Consultancy
Water Systems Validation (WFI, PW and Pure Steam) – Strategic Consultancy
Water Systems Validation (WFI, PW and Pure Steam) – Routine Support
Computerized Systems Validation Landscape – Operational Documents Creation
Master Data Management (Computerized Systems)– Strategy Definition
Computerized Systems Implementation – Project Management with Quality Focus
Computerized Systems Validation Audit Readiness – Strategy Definition
Computerized Systems Validation Audit Readiness – GAP Assessment
Master Data Management (Computerized Systems) – Workshop and Trainings
Access Management (Computerized Systems) – Workshop and Trainings
Computerized Systems Validation Audit Readiness – CAPA Plan Management
Computerized Systems Validation Audit Readiness – Audit Execution
Computerized Systems Validation Audit Readiness – Workshop and Trainings
Quality Management Systems Landscape – Operational Documents Creation
Water Systems Validation (WFI, PW and Pure Steam) – Strategy Definition
Water Systems Validation (WFI, PW and Pure Steam) – Operational Documents Creation
Water Systems Validation (WFI, PW and Pure Steam) – GAP Assessment
Water Systems Validation (WFI, PW and Pure Steam) – Project Management
Water Systems Validation (WFI, PW and Pure Steam) – Workshop and Trainings
Medical Devices EU Registration – Implementation and Improvement
Nitrosamines: Compliance with requirements - Implementation and Improvement
Safe use of AI tools in Quality: Data Security and Process Optimization
Nitrosamines – Drug Substance Risk Management Strategy Creation (for NDSRI)
