Scale-up of processes and introduction in operations
Improving quality by reducing deviations or removing impurities
Growth media development
Analyses, modelling, and fit-for-plant studies
From process development until process validation
Interactions with other CMC areas such as QC
Establishing and maintaining compliance with Regulatory, GMP and SHE requirements
Specific strengths
- USP, in particular microbial fermentation
- Vaccines
- Veterinary and Animal Health
Business processes
Tech transfers, both from R&D to Manufacturing and from one site to another
Risk assessments and Quality by Design
Conducting assessments of potential C(D)MO partners
Establishing and running a Tier or daily Visual Management system
Lean project management using A3s
Dynamic Work Design or Business Process Design
Effective Business Performance Management
Specific strengths
- Deploying Lean practices in a project environment such as Tech Ops or R&D
- Analysing and challenging the current state
- Improving the effectiveness of your team's Business Performance Review. More information on this specific service can be found on https://tripleloop-consulting.com
Organisation
Developing, executing and translating strategy with engagement from employees
Coaching and development of professionals
Change management
Lean leadership and behaviours
Organisational design
Opportunity assessments
Interim management
Specific strengths
- Establishing and executing a strategic vision
- Coaching of professionals in R&D and Technical Operations
