Consulting Services
We provide services for pharmaceutical and medical device industry covering pharmaceutical products, medical devices and drug-device combination products:
Consulting
- Quality Management in general
- QMS System Review and Implementation
- GMP and Regulatory Compliance
- Annex 1 implementation
- Implementation of GMP, ISO and FDA standards
- Gap Assessments / Process Mappings / Six Sigma / Business Process Excellence
- Process Maturity and Process Excellence Assessments
- Inspection Readiness & Preparation for Authority Inspections
- Due Diligence
- Quality Risk Management
- Investigation and Out-of-specification Support
- Lead auditor for GMP-related areas, EN 13485:2015 and EN 9001:2016
- 3rd Party Management
- Establishment of new Quality Processes
- Quality Control and Analytical Method Development / Validation
- Transfer of Analytical Methods
- Conception and Performance of Training Sessions worldwide
- Updating and Writing SOP's and Documents
- Training
Interim Management:
- Quality Assurance Units
- Quality Control Units
- Project Management Organizations
Project Management of:
- Product Development Teams
- Inspection Readiness Teams
- International, Global Project Teams
- Transformation Projects
- Remediation Projects