Leaders in GxP Compliance
Experienced Consultants in Pharmaceutical, Medical Device, and Biotechnology Regulations.
What We Do
Supplier Assessment
Our Supplier Assessment Team consists of qualified auditors to support the Life Sciences industry and audit per CFRs and ISO (including including ISO 13485, MDSAP, 21 CFR 820, and 21 CFR 211). Our experienced team can supplement your organization by leading supplier quality audits so you can focus your resources elsewhere.
Inspection Readiness
Our consultants will help you identify the essential activities to become inspection ready, including systems and documentation gap analysis, correction of any identified gaps, training staff on inspection flow and logistics, including facilitation of a mock inspection.
Project Strategy
Our Team members bring a wealth of experience managing changes in regulated industry. We can offer guidance and support with respect to validation and documentation. . Our track record proves that clear communication and expert collaboration lead to positive results.