Range of services

Consultant for Compliance of Quality Processes within Medical and Pharmaceutical Industry

FDA CFR part 3, 4, 210, 211 and 820
Conducting and Review of documentation: cGMP, GDP, URS, QNA, FMEA, ISO 13485,ISO 14971, DQ, IQ, OQ, PQ
Design Control and Verification

Auditing, Self Inspection

Supporting Audits
Conducting Self Inspections
FDA readyness projects Pharma and Medical Industry

Validation of Packaging and Transport processes

Pharmaceutical and Medical packaging process
GDP Transport validation
GMP documentation
Conducting of transport validation tests, statistics, documentation

MDR Implementation Projects

Validation of Pharmaceutical and Medical Development and Production Processes

Qualification of Production lines
clean rooms

Supporting FDA readyness projects for medical products

Leading of international development projects

MDR Implementation
UDI standards and technical requirements
Harmonization of packaging tools

Quality control

Sampling and Release processes
Testing procedures

Supplier Qualification


Support of Change Control Process (CAPA)