Gap assessments, SOP updates, and pre-audit preparation to help you pass with confidence.
Outdated or incomplete SOPs and documentation
No formal gap assessment process in place
Limited staff familiarity with compliance standards
Last-minute scrambling before inspections
Pre-audit gap assessments with prioritized recommendations
Compliance checklists aligned to GMP, ISO-9001, CFR 111 & 117
Mock audit walkthroughs to build readiness
Updates to align with regulatory changes or internal standards
Document control systems for version tracking and accountability
Staff training on compliance protocols and inspection procedures
Continuous improvement strategies to maintain compliance year-round
Let’s strategize how to get you there.