Quality Assurance

Our experts have in-depth understanding of the ICH Q10, GMP, and ISO 9000:2005 to work with you on all aspects of building, implementing or improving your quality systems. We can help build your quality system, from writing a quality manual through providing resources to implement and maintain your systems, to ensure product quality and maximize your process capabilities through the entire product development lifecycle. We can also assist with the structure of management reviews to ensure that your senior management team is appraised of your system in a concise and expeditious manner

Key Offerings

Change Control Program Development

GMP, GLP, QSR, and Part 11 Compliance

GAP analysis of critical documents, systems, procedures and policies

CAPA Development/Support