What we do
GxP Consulting Services
Built for Biopharma
We support biopharmaceutical manufacturers and CDMOs in achieving world-class GMP execution. From sterile injectables and vaccines to biosimilars and monoclonal antibodies, our senior consultants bring hands-on expertise in sterility assurance, Annex 1 compliance, contamination control, and batch release optimization. We help you simplify complex Quality challenges, strengthen regulatory trust, and ensure uninterrupted supply.
Built for Biotech & Advanced Therapies
For biotech innovators and cell & gene therapy (CGT) companies, we provide tailored GMP consulting from early clinical development through commercial scale-up. Whether you’re preparing an IND/IMPD, establishing your first Quality Management System (QMS), or managing CDMOs for late-phase production, we bridge science, manufacturing, and compliance. Our goal: secure faster approvals, reduce compliance risks, and give investors confidence in your operations.