Production
We help your organisation to build efficient and lean production processes that meet regulatory standards.
- Development of production concepts
With you we define criteria for production facilities (location, resources, budgets) and carry out GMP risk assessments.
- Transfer of R&D processes to manufacturing
We help you to transform R&D processes to GMP scale-up and final production. We implement realistic and practical changes to medical and pharmaceutical production to meet newest FDA/EMEA and CE mark guidelines. We integrate and review CMC plans for API and pharmaceutical production. We plan, build and optimise production of blood products and blood related diagnostics.We plan, build and review clean room production of medical products.
- Optimisation of production processes
Audits and evaluation of current GMP-status, Optimisation of supply chain.
- Realisation of innovation and productivity potentials
We help your company to lift currently unexploited potential trough lean production and Six Sigma. We follow the principle "Quality by Design" in realising Implementation, validation and verification of PAT. We also support you in Change management.
- Outsourcing of production
Search and evaluation of suppliers, Assessment of production facilities to meet GMP standards.
