Inspection Readiness
✤ We have over 100+ combined years of consulting with our experienced consultants and have been operating for over a decade on the global market.
✤ We can quickly utilise our GXP compliance expertise to guide you through the various agency regulations such as the FDA, EMA, MHRA, PMDA (Japanese), SDA (Chinese), KFDA (Korean), TGA (Australian), ANVISA (Brazilian), CDSCO (Indian), Health Canada etc. because we are cognisant that any breaches in compliance can derail your entire clinical program and be devastating for your brand and investors.
✤ We have extensive experience in regulations such as CFR 600’s, 820’s, 210, 211, 58, 50, 54, 314, 312, Part 11, ICH E6 Rev 02, 21CFR 1271 etc.
✤ We can prepare for and lead Mock Inspections for BiMOs and PAIs and other types of inspections such as FDA routine inspections(including both on-site and virtual)
✤ Help host pre-approval inspections (BIMOs and PAIs). We provide hosting, front/back room support, mock interviews, readiness assessments, and application conformance reviews. We help you prepare by reviewing hosting processes, site presentations, and tour routes.
We are an American multinational firm that can work seamlessly to provide
compliance solutions for established and emerging, small and mid-sized
Biopharmaceutical and Pharmaceutical firms throughout the globe.
The GXP Compliance Experts.
We have never failed a BiMO or PAI inspection and we have remediated many failed BiMOs and PAI’s ectors for over a decade