Are you looking for help with
- Production setup
- Technical / Design transfer
- Robust Design / Design for Manufacture
- Validation / Verification / Qualification
- Data analysis and statistics
for Medical Devices, within Biotech or in the Pharmaceutical industry?
Or do you need an extra hand with Quality tasks in your QMS system?
We support the Ukrainian fight against oppression
Consulting
Process Design | Robust Design | Design for Manufacture | Commissioning/Upscaling of pilot equipment to full scale production systems | Validation and Verification | Design Control | Tech Transfer | Lean tools | Statistical methods
GMP compliance | QMS (ISO 9001, ISO13485) | Quality planning |Risik Management (ISO14971) | Problem Solving (e.g. Root Cause Analysis) | Compliance
Design of Experiments (DoE) | 6-sigma Tools | Data Analysis |Process Control (SPC) | Sample Size Planning