Quality Management Consulting
We support your R&D, Operations and QA/QC departments providing consulting within GxP Compliance (GLP, GCP, GMP, GDP, ISO, ICH) and processes to help you maintain and secure that cGxP requirements are met, prepare for external audits, optimize your processes in order to simplify and reduce quality costs – still within the framework of patient safety and compliance.
We help perform tasks within quality consulting e.g.
- Establish new or revise existing quality management systems e.g before being certified by ISO9001 or ISO13485
- Help prepare etablishment of quality management system for FDA regulations or §39 Licence to Operate by EMA
- Value stream mapping of your quality processes to identify compliance gaps and waste
- Review of SOPs and quality processes and give our recommendations to fill in compliance GAPs and LEAN the processes
- Process analyses, troubleshooting, root cause analyses, gap analyses, risk analyses, statistical analyses, process verifications etc.
Our other services:
- Product Release Support
- Compliance Remediation
- Individual Quality Management Coaching
- Regulatory Consulting