Pharmaceutical
Quality
Services
PHARMACEUTICAL– Quality Solutions
Quality Management Systems
- Quality system creation and/or remediation
- Strategic assessment, compliance, gap and optimization
- New standards and regulation optimization (EUMDR, MDSAP, etc.)
- Quality and compliance audits
- Medical device regulation training
Quality Systems
- Risk Management
- Design Controls
- Combination Devices
- Document Controls
- Purchasing controls: supplier controls & audits
- Manufacturing and operations change management
- Process validation
- Acceptance activities
- CAPA
- Device listing and complaint handling
Crisis Management, Acquisition and Agency Support
- Device listing and complaint handling
- Formulating responses to 483s and Warning Letters
- Interim QA leadership to guide through crisis management situations
- M&A due diligence
- Quality systems acquisition integration planning
