Ensuring quality and regulatory compliance isn’t all about audits.  Sometimes you just need some advice. Perhaps you are new to pharma research or manufacturing and need help determining what to focus on first. Or maybe you are an industry veteran looking for feedback on a Part 11 gap analysis or computer systems risk assessment. And maybe you need something in between.

Our team can act as an extension of your own by providing the strategic consulting and technical advice you need.

​Here are some of the ways we’ve been able to help our clients.

• Provide strategic advice pertaining to Quality and Compliance aspects of drug development
• Provide Supplemental Staffing of Quality and Compliance personnel
• Development of a Quality Management System (QMS) Requirements Document
• Manage the Selection Process of a commercial QMS

Compliance & quality consulting for your business success

Contact Us To Begin