Biotechnology

Regulatory Compliance Associates Inc. is dedicated to providing value-driven compliance solutions that are sensitive to business needs.  Our well tailored approach to compliance allows us to carefully evaluate each project and determine the correct level of remediation effort required, thus permitting us to maximize value for both large and small projects. The RCA team is comprised of industry experts with technical compliance expertise in the biotechnology industry.  Our personnel are equipped to offer best practice solutions and effective, efficient implementation.

Regulatory Compliance Associates Inc. will help you achieve compliance goals in a variety of regulatory scenarios, including:

• Product Development
• Design Control
• Risk Management
• Facility and Equipment Validation
• Process Validation
• Computer Validation
• Quality System Development and Remediation
• Management of Change
• CAPA Remediation
• Document Management
• Quality and Regulatory Training
• Aseptic Processing
• Good Documentation Practice
• Good Manufacturing Practices
• Good Laboratory Practices
• Good Clinical Practices
• Manufacturing Optimization
• Project Management
• Metrology and Calibration
• Technology Transfer
• Quality and Supplier Audits