QSC can provide your company with strong technical and practical experience in the following areas:
Quality Systems Development
- Assessing, Planning, Developing and Implementing Quality Systems that are engineered to be sustainable long after our consultants have left your site
Compliance Projects
- FDA 483 and Warning Letter Response Assistance and Remediation
- Data Integrity Audits, Product Quality Assessments, Third Party Quality Oversight
Deviation Management
- Deviation and OOS Investigation closure assistance
- Corrective and Preventive Action closure assistance
Validation Projects
- Manufacturing Processes, Laboratory and Manufacturing Equipment, Cleaning and Sterilization Processes, Analytical Methods, Computerized Systems, and Facilities
Project Management
- PMP Certified Consultants with proven Project Management skills and experience within the regulated environment of the Life Sciences Industry