Quality & Regulatory Compliance

Driving Quality and Regulatory Compliance

In response to increasingly stringent regulatory requirements, we enable our clients to ensure compliance by:

• Establishing Quality Management Systems that comply with all relevant regulatory requirements and ISO standards.
• Implementing global quality management programs that develop staff understanding and commitment to quality.
• Providing comprehensive and professional quality auditing, including support for GMP, GLP, GDP and PAI inspections by all the major regulators.
• Devising and supporting remediation programs.
• Improving CAPA programs so that they are effective and lead to sustainable improvement.
• Managing and supporting Computer Related System compliance and validation programs in compliance with 21 CFR Part 11 and GAMP requirements.

See following pages for additional information on:

• Quality Management System Design and Implementation
• GMP Compliance Auditing
• QA Management and Support
• Remediation Management and Support
• CAPA Process Improvements
• Computer System Compliance