MIVADO GlobalPerformance
Mivado GlobalPerformance is dedicated to creating meaningful connections, innovative solutions, and seamless experiences in the fields of GXP validation, compliance, digital transformation, artificial intelligence, process optimization, and quality risk management. The company offers a wide range of services including validation, training, consulting, and solutions to help organizations optimize their manufacturing and business processes, ensure regulatory compliance, and leverage advanced technologies for operational excellence. It also provides expertise in quality assurance, regulatory compliance, project management, manufacturing process optimization, and continuous improvement, serving clients across pharmaceutical, medical, agro-food, cannabis, and biopharmaceutical industries.
Industries
Nr. of Employees
small (1-50)
MIVADO GlobalPerformance
Products
AI readiness and transformation assessment
Assessment of organisational readiness for AI across strategy, infrastructure, data, governance, talent and culture to inform an AI transformation roadmap.
Conversational AI / NLP implementations
Design and deployment of conversational AI assistants for customer support and internal workflows using natural language processing and integration with business systems.
AI training and deployment workshops
Workshops and training programs to upskill teams on AI use, deployment and integration with existing workflows, including practical hands‑on sessions and case studies.
AI readiness and transformation assessment
Assessment of organisational readiness for AI across strategy, infrastructure, data, governance, talent and culture to inform an AI transformation roadmap.
Conversational AI / NLP implementations
Design and deployment of conversational AI assistants for customer support and internal workflows using natural language processing and integration with business systems.
AI training and deployment workshops
Workshops and training programs to upskill teams on AI use, deployment and integration with existing workflows, including practical hands‑on sessions and case studies.
Services
Consulting and execution across validation lifecycle activities including development of validation master plans, commissioning/qualification (CQV) of facilities, IQ/OQ/PQ protocols and periodic review programs.
Risk‑based CSV planning and execution for software and automation systems in GxP environments, covering CSV lifecycle documentation, change control, data integrity and alignment with Annex 11 / 21 CFR Part 11 expectations.
Engineering support for upstream and downstream process design, PFD/P&ID development, equipment specification, utility calculations and scale‑up strategies from bench to commercial manufacture.
Design and implementation of data lifecycle mapping, SOPs, system inventory, data risk assessments and controls to secure data integrity and support regulatory expectations for GxP data.
Operational excellence engagements applying Lean, Six Sigma, DFSS and DMAIC to reduce waste, improve OEE and implement continuous improvement in manufacturing and service processes.
Support for establishment and execution of annual product review programs, stability study management, deviation and CAPA oversight, and alignment of QA/QC processes between customers and suppliers.
Consulting and execution across validation lifecycle activities including development of validation master plans, commissioning/qualification (CQV) of facilities, IQ/OQ/PQ protocols and periodic review programs.
Risk‑based CSV planning and execution for software and automation systems in GxP environments, covering CSV lifecycle documentation, change control, data integrity and alignment with Annex 11 / 21 CFR Part 11 expectations.
Engineering support for upstream and downstream process design, PFD/P&ID development, equipment specification, utility calculations and scale‑up strategies from bench to commercial manufacture.
Design and implementation of data lifecycle mapping, SOPs, system inventory, data risk assessments and controls to secure data integrity and support regulatory expectations for GxP data.
Operational excellence engagements applying Lean, Six Sigma, DFSS and DMAIC to reduce waste, improve OEE and implement continuous improvement in manufacturing and service processes.
Support for establishment and execution of annual product review programs, stability study management, deviation and CAPA oversight, and alignment of QA/QC processes between customers and suppliers.
Expertise Areas
- GxP compliance and regulatory affairs
- Validation lifecycle management and commissioning (VMP, CQV, IQ/OQ/PQ)
- Computerized system validation and digital compliance (Annex 11 / 21 CFR Part 11)
- Bioprocess engineering and scale‑up (upstream and downstream)
Key Technologies
- Process analytical technology (PAT)
- Predictive analytics and machine learning
- AI deployment and workflow automation (cloud-based AI)
- Process simulation software