Quality System Management
GxP Validation Services Consultants offers a full range of services to the healthcare industry. Our services are focused on assisting medical device, pharmaceutical and food companies achieve regulatory and standard compliance with U.S., European and Canadian agencies and organizations.
- Internal and External Audit Preparedness
- Create and Review Change Controls and Life Cycle Deliverables
- FDA Good Manufacturing Practices (GMP), Quality System Regulation (QSR) Development and Compliance
- FDA Quality System Audit Inspection Support
- FDA Regulation Interpretation and Guidance
- International Regulatory Compliance
- Quality and Regulatory Affairs Management
- Quality System Registrar Interface, Quality System Selection and Development
- Reply to FDA Inspection Observations Form 483
- 21 CFR Part 11 Assessment
- Warning Letter Response
- HIPPA Compliance