Quality, Compliance, and Regulatory

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

CAI employees in this business area are experienced, certified professionals and industry leaders with strong participation in industry professional societies including PDA, ISPE, and RAPs.

All CAI employees are strongly versed in risk- and science-based approaches to compliance ensuring that resources are product- and process-focused.

Let us apply our knowledge, systems, and people to your challenges to generate compliant, efficient solutions.

At CAI, we create quality systems and raise quality awareness so you consistently deliver high quality products to your customers. We have met the challenges in developing, implementing, and sustaining efficient, effective, and compliant quality management systems for both ISO certification and worldwide GMP compliance. Effective quality management systems must be linked through procedures, tracking systems, approvers, and responsible parties. We are experts in implementing these systems in a variety of industries.

In addition, we can develop a robust regulatory submission strategy, whether this is your first regulated product approval or you have a diverse product portfolio balancing new product introductions with post-approval changes.

This service listing provides a broad outline of our services offered to clients. If your need is not specifically addressed, please contact us as we offered tailored solutions to meet all your needs.

Our Quality, Compliance, & Regulatory Services:

• Quality Culture assessment, education, and deployment
• Quality Risk Management program deployment
• Quality Metrics program deployment
• Data Integrity programs
• Regulatory submissions and strategy (510k, PMA, NDA, BLA, IND, IMPD, EU CP and DCP etc.)
• Auditing (cGMP, QP Certification, Supplier, Internal, Process)
• EU Qualified Person services
• CMO capacity and feasibility analysis
• Compliance remediation
• GMP & ISO Quality Management System development, implementation and improvement
• Standards assessments including gap analysis
• Supplier Quality Management program implementation
• Investigation and Root Cause Analysis program implementation
• Quality management review implementation
• Stability program development
• Permanent Inspection readiness programs
• Assistance with FDA and other Competent Authority meetings (requesting, preparing for, and conducting)