RBQM SOP & Gap Analysis

MyRBQM Functional Service Provision

SOP Compliance Assessment

Assessment of SOPs against relevant regulations

SOP Gap Analysis

Identification of gaps in compliance

SOP Consistency

Ensure consistency amongst your SOPs

Be Audit and Inspection Ready

Regulatory compliance is not optional – be audit and inspection-ready! Subscribe to independent, unbiased SOP assessments and ensure ICH E6 and ICH E8 compliance and SOP consistency.

  • Assessment of SOPs against relevant regulatory guidelines

  • Identification of gaps in compliance

  • Ensure consistency amongst your SOPs

Would you like to optimize in the area of:

  • Inconsistent SOPs

    • As your organization matures and develops, making sure all SOPs are mutually consistent becomes increasingly challenging.
  • Regulatory Compliance

    • Staying compliant in an ever-changing regulatory environment may be challenging.

SOP Optimization Opportunities

Explore how we can support you:

  • SOP Consistency

    • We guarantee 100% consistency between your SOPs.
  • Audit-and Inspection Readiness

    • We guarantee 100% compliance with the latest proposed regulations.

MyRBQM Your Functional Service Partner!

Navigating Optimization Together

Step 1

Access & Review of Existing SOPs

Step 2

Perform Gap Analysis

Step 3

Provide Proposals, Corrections, Amendments & Crosschecks

Step 4

Stakeholder Discussion

Step 5

SOP Change Proposal & Training

Get the Advice of Our FSP Experts

RBQM transformation starts here.

Explore Our Other Functional Services

  • Study protocol risk assessment & mitigation

Holistic risk-based quality management starts with de-risking the protocol before your study goes live. Identification of potential issues that may arise is crucial to effective risk assessment before the study begins. We help you proactively drive quality by designing quality into the study protocol.   

  • Centralized Monitoring

Centralized Monitoring within a risk-based framework can alleviate many of the considerable barriers compared to traditional site-based studies. Our team of experienced Central Monitors helps you oversee the conduct of your trial and timely address risks while the study is ongoing.

  • Quality of Clinical Data Report

Unbiased, customizable Quality of Clinical Data Report, meticulously crafted to complement the clinical due diligence process. By furnishing a reliable, unbiased, and comprehensive clinical data assessment, buyers can confidently make informed decisions in pharmaceutical M&A.