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