Achieve Your Goals

Inspection Readiness

Be prepared — every day — for regulatory inspections by the FDA, EMA, MHRA, and other global agencies.

We help organizations establish a proactive inspection readiness culture through

TMF readiness assessments & remediation.
Mock audits & gap analyses.
Investigator site file (ISF) checks & study-level documentation reviews.
Inspection training for teams & leadership.
Deficiency tracking, CAPA development, and effectiveness checks.

Systems supported

eTMF, CTMS, EDC, eCOA, IRT, Safety Databases, PV Systems.