QUALITY & COMPLIANCE
CONSULTING AND SUPPORT FOR ALL PROCESSES
We accompany our customers on their way to the implementation of all regulatory requirements during the planning and construction of their production facilities, during the establishment of new processes and throughout the entire product life cycle from development through the clinical phases to production.
Quality Experts
- Demand-oriented and risk-based preparation of qualification and validation concepts for large-scale projects
- Execution of qualification and validation of facilities and rooms
- Preparation of all necessary operational documents such as work instructions / SOPs and rationales
- Product transfer to other production sites and CMOs
- CSV andy data integrity
- Preparation of process risk analyses (CPP, CQA, CMA)
- Change control, deviation and CAPA management
- Managed QA Services
- Quality Oversight Services
GMP-Consulting
- Consulting for current guidelines (Annex 1 Assessment, CCS)
- Execution of self-inspection
- Organization and support of inspections by authorities
- GMP-Readiness for machine suppliers
Mr. Christian Gavranovic
is your contact for the area of QUALITY & COMPLIANCE