At BIMO Pro,
we’ve got you covered!
✓ Remediation & FDA 483 Response
✓ Phase II–III Transition Strategy
✓ Inspection Readiness
✓ SOP Development
✓ Investigator Site, Vendor &
Mock FDA Audits
✓ Training
Discover Our Clinical Quality Services
Remediation &
FDA 483 Response
Navigate the critical handoff between clinical phases with confidence. I help sponsors and CROs develop actionable transition plans, identify protocol or process gaps, and remediate issues before they impact Phase III outcomes.
SOP Development
Protect your data and subjects by ensuring site compliance. We conduct comprehensive audits of investigator sites to evaluate protocol adherence, data integrity, and Good Clinical Practice (GCP) implementation.
Phase II–III
Transition Strategy
I evaluate your existing quality systems to uncover vulnerabilities—then create or refine SOPs that align with GCP standards. Whether proactive or post-audit, my assessments ensure your documentation stands up to scrutiny.
Investigator Site, Vendor & Mock FDA Audits
Simulate the real thing. My tailored mock audits replicate FDA expectations to uncover potential gaps in vendor oversight, site conduct, or internal systems—before regulators do.
Inspection Readiness
Be audit-ready, always. I prepare teams, systems, and documentation to withstand regulatory inspections—from FDA to EMA—through mock audits, readiness training, and corrective action planning.
Training
From internal compliance checks to third-party vendor audits, we bring an objective lens and regulatory expertise to every engagement. Our audits are structured, efficient, and always aligned with your business and quality goals.
Contact Us
Ready for inspection-ready confidence? Let’s talk.
Reach out today to schedule a consultation or learn more about how we can support your clinical compliance goals.