The success of your business is intrinsically linked to quality. Our compliance team understands this and works closely with technical experts in nonclinical development and CMC to ensure phase-appropriate application of key GLP and GMP elements. We will design standalone quality management systems (QMS) tailored to your business and to meet applicable regulations, while incorporating a life cycle approach focused on continuous improvement.
Our services are flexible, whether you need to establish a new QMS to address the core elements of your business, enhance or improve an existing QMS, or establish a “rescue plan” related to specific regulatory compliance problems. Services include: