We are proud of our near-perfect compliance record. We undergo over a hundred of client and regulatory authority audits annually and continually improve our operations as a result of these inquiries.
Our team is staffed by experienced, senior-level auditors and compliance professionals who have conducted audits across the globe. They possess a diverse range of experience, including regulatory, analytical, microbiology and biotechnology laboratories, non-sterile and sterile clinical supplies and marketed product manufacturing, packaging, labeling and project management.
We also have expertise in sterile and non-sterile facilities, CTM and marketed product manufacturing, controlled substances requirements and Good Manufacturing Practice (GMP) operations. Our strict adherence to the most rigorous pharmaceutical quality standards has resulted in a long history of successful GMP, general FDA and Pre-Approval Inspections.