We complement, enhance and reinforce your team, adding our strengths to yours.
We are experts in quality assurance, US FDA and international regulatory affairs, operations, manufacturing, validation, information technology and human resources. We provide our clients, around the world, with a broad range of services including:
- Regulatory Submissions (PMA, 510(k), 513(g), NDA, ANDA, BLA, etc.)
- Regulatory Inspection Management and Support
- Clinical Study Design, Monitoring and Auditing
- Quality System Development and Deployment
- Computer Technology Deployment and Validation
- Design Control and Design Validation Services
- Process Design and Development
- Process Validation and Equipment Qualification
- Cleanroom Commissioning and Validation
- Risk Management Services
- Quality Problem Investigations and Root Cause Analysis
- Quality or Regulatory Crises Management
- FDA-483, Warning Letter and Consent Decree Resolution
- Expert Auditing and Situation Analysis
- Corrective Action Plan Generation and Execution
- Training, Staffing, and Organizational Development
- Technology and Organizational Competency Analysis