Dahlia Consulting
Dahlia Consulting is dedicated to creating a transformative impact in the lives of patients worldwide by partnering with clients to achieve great results in the life science industry. They focus on quality, agility, passion, and reputation, and specialize in the innovative fields of cell and gene therapy. Their team of consultants is known for uncovering possibilities, defining high-level plans, and executing with meticulous detail, addressing challenges such as regulatory compliance, clinical trial management, and commercialization strategies. They support the entire lifecycle of cell and gene therapy products, from R&D to market access, ensuring their clients meet industry standards and pioneer new ones.
Industries
Nr. of Employees
small (1-50)
Dahlia Consulting
Products
Organizational Design
Organizational Change Management (OCM) is a framework for managing the effect of new business processes, new technology, shifting economic landscapes or change in organizational structures and culture within an organization.
Organizational Design and Deployment
Dahlia will partner with the client to design and deploy the organization based on a capability assessment analysis.
Environmental Monitoring Performance Qualification
Assessment of facility processing environment to determine those areas that have the highest risks.
EMPQ (Environmental Monitoring Performance Qualification)
Prepares protocols and schedules for environmental monitoring performance qualification and integrates them into the project plan.
Product Commercialization Strategy
An embedded consulting model that acts as a seamless extension to your teams to enhance cross-functional knowledge and agile orchestration across process and manufacturing technical services, regulatory, clinical, patient operations, manufacturing, supply chain, quality compliance, and program management.
Cell and Gene Therapy Consulting
Consulting services focused on cell and gene therapy manufacturing, marketing, advanced manufacturing techniques, quality control, supply chain optimization, and regulatory compliance.
Organizational Design
Organizational Change Management (OCM) is a framework for managing the effect of new business processes, new technology, shifting economic landscapes or change in organizational structures and culture within an organization.
Organizational Design and Deployment
Dahlia will partner with the client to design and deploy the organization based on a capability assessment analysis.
Environmental Monitoring Performance Qualification
Assessment of facility processing environment to determine those areas that have the highest risks.
EMPQ (Environmental Monitoring Performance Qualification)
Prepares protocols and schedules for environmental monitoring performance qualification and integrates them into the project plan.
Product Commercialization Strategy
An embedded consulting model that acts as a seamless extension to your teams to enhance cross-functional knowledge and agile orchestration across process and manufacturing technical services, regulatory, clinical, patient operations, manufacturing, supply chain, quality compliance, and program management.
Cell and Gene Therapy Consulting
Consulting services focused on cell and gene therapy manufacturing, marketing, advanced manufacturing techniques, quality control, supply chain optimization, and regulatory compliance.
Services
End-to-end advisory and management for facility site selection, design development, permitting, construction oversight, commissioning and financial closeout.
Assess and prepare facilities for safe and efficient startup to achieve target throughput and controlled operations.
Support master batch record design, MES/ERP requirements, CDMO liaison, production management, capacity modeling and supply chain strategy.
CIO advisory, IT strategy and security roadmaps, technology selection and negotiation, vendor selection and IT operations support.
Business operations assessments, PMO establishment, operating model design, organizational design and change management, operational excellence programs.
Advisory on regulatory compliance, quality systems, environmental monitoring and performance qualification for facility and manufacturing readiness.
End-to-end advisory and management for facility site selection, design development, permitting, construction oversight, commissioning and financial closeout.
Assess and prepare facilities for safe and efficient startup to achieve target throughput and controlled operations.
Support master batch record design, MES/ERP requirements, CDMO liaison, production management, capacity modeling and supply chain strategy.
CIO advisory, IT strategy and security roadmaps, technology selection and negotiation, vendor selection and IT operations support.
Business operations assessments, PMO establishment, operating model design, organizational design and change management, operational excellence programs.
Advisory on regulatory compliance, quality systems, environmental monitoring and performance qualification for facility and manufacturing readiness.
Expertise Areas
- Cell and gene therapy operations
- Facility design, construction and commissioning
- Manufacturing operations and CDMO coordination
- Supply chain strategy and capacity planning
Key Technologies
- Manufacturing Execution Systems (MES)
- Enterprise Resource Planning (ERP) systems
- IT security frameworks and incident response planning
- Capacity modeling and production scheduling tools