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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

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Gap Assessments,
Remediation &
FDA 483 Response

Whether proactive or post-audit, our assessments ensure your documentation stands up to scrutiny. We identify protocol or process gaps, and remediate issues before they impact business outcomes.

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SOP Development

We evaluate your existing quality systems to uncover vulnerabilities—then create or refine SOPs that align with regulatory standards, including ICH E6(R3) guidelines.

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Phase II–III
Transition Strategy

We evaluate your existing quality systems to uncover vulnerabilities and help sponsors develop actionable transition plans. The result? You navigate the critical handoff between clinical phases with confidence.

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Investigator Site, Vendor & Mock FDA Audits

Ensure flawless study execution that aligns with U.S. FDA regulations, ICH E6(R3) guidelines, and Good Clinical Practice (GCP). Our audits are structured, efficient, and always aligned with your business and quality goals.

Investigator Sites: We evaluate protocol adherence, verify data integrity, and ensure proper trial conduct.

Vendor Audits: We assess vendor compliance with quality systems, and review sponsor plans & policies.

Mock FDA Audits: We simulate inspections, identify risks early, and support readiness planning.

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Inspection Readiness

Be audit-ready, always. We prepare teams, assess systems, and critique documentation and processes to withstand regulatory inspections—from FDA to EMA—through mock audits, inspection readiness training, and corrective and preventative action planning.

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Training

From structured sessions to interactive role play and case-based scenarios, we bring an objective lens and regulatory expertise to cross-functional teams.

Contact Us

Ready for regulatory 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.