Quality Consulting Regulatory, Quality Regulatory Consulting, Quality System Development, Regulatory Consultants Biotechnology, Regulatory Consultants PharmaceuticalsWhat We Do

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
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