Regulatory & Audit Readiness Fast-Track

Partner with qointa for Confidence in Compliance

With qointa, you’re not just buying a service — you’re gaining a global compliance partner. We help you reduce risk, accelerate timelines, and protect the integrity of your trial data.

→ Get Started with our Fast-Track

Be Inspection-Ready in Weeks, Not Months

qointas Fast-Track program delivers rapid gap analysis, documentation remediation, and mock-audit support for decentralized and hybrid clinical trials.

 The Challenge

Evolving regulations and global study footprints make inspection preparedness a constant challenge.
Incomplete documentation, unvalidated workflows, or unclear responsibilities can trigger costly delays.

Our Solution

Our Regulatory & Audit Readiness Fast-Track gives your teams an accelerated path to compliance and confidence before first-patient enrollment.

Services include:

  • DHT regulatory and documentation review (FDA, EMA, MDR)

  • Inspection binder creation

  • CAPA and FSCA response templates

  • Mock audits and corrective action planning

  • Targeted retraining for study teams

Outcomes:

  • Early detection of compliance gaps

  • Reduced regulatory risk

  • Aligned global documentation

  • Streamlined audit responses

Engagement Model

  1. Discovery Call — Define scope and regulatory focus

  2. Gap Assessment — Review study documentation and systems

  3. Remediation Sprint — Implement fixes, train teams, and validate

  4. Mock Audit — Final readiness check with report and recommendations