Compliance

The experts at Raland Technologies understand the importance and urgency of industry requirements and can manage every step of the process for you.

Our associates have decades of experience designing, training, implementing, and auditing compliance programs in the areas of Quality Operation, Risk Management, and Gap Assessment for compliance with biotechnology, medical device and pharmaceutical industry regulations (FDA, MHRA, KFDA). We work to ensure you’re compliant.

Areas of Expertise

• FDA 483 Remediation and Corrective Action Preventative Action (CAPA)
• Conducting Validity Assessments of BLAs, NDAs and ANDAs
• Training and Education in GxP (GMP, GLP, GCP)
• SOPs for Quality Systems including Good Document Practices (GDP)
• Validation and Quality Assurance Systems Gap Analysis
• Software Quality Assurance
• Vendor Qualification (Initial qualification and inspection of suppliers, contract manufacturing, testing laboratories, and software developers)
• Laboratory Method Development and Validation
• Laboratory Equipment Validation