Overview

• Founded in 2012 and headquartered in Caguas, Puerto Rico, with a team of 8 employees
• Specializes in staffing and consulting services for pharmaceutical, medical device, and biotechnology industries
• Provides targeted support for FDA-regulated industries facing consent decree challenges
• Focuses on technology transfer and computer system validation within regulated environments
• Serves clients requiring project management and documentation expertise in quality assurance/control

Specializations

• Pharmaceutical industry staffing with expertise in regulatory compliance and validation services
• Medical device sector support for documentation and technology transfer processes
• Biotechnology industry staffing focused on quality control and project management
• Regulatory Compliance Services addressing consent decree remediation for manufacturing facilities

Services & Approach

• Regulatory Compliance staffing solutions for FDA-regulated pharmaceutical operations
• Validation services staffing including computer system validation (CSV) and equipment qualification
• Documentation specialists for quality assurance protocols and compliance reporting
• Consent Decree remediation staffing for manufacturing practices and audit preparedness