Gap Analysis & Mock Audit
Pre-audit 'Full Physical Exam'
Identify risks before the official audit to avoid being blacklisted or downgraded. QTC helps you identify 'red line' issues in advance through full simulation.
Diagnosis Trilogy
Comprehensive, blind-spot-free compliance scanning, ensuring no hidden risks escape the auditor's eyes.
On-site Diagnosis
Simulating the auditor's perspective, conduct a blanket check of production workshops, warehouses, dormitories to identify risks.
Document Review
Deeply verify past 12 months' payroll, social security vouchers, EHS permits to identify logical loopholes via cross-verification.
Management Interview
In-depth interviews with HR, EHS heads, and management representatives to assess system maturity.
Gap Analysis Diagnostic Report
You will receive a detailed diagnostic report, not just listing problems, but providing priority recommendations based on risk levels (Critical / Major / Minor).
- Identify Critical Defects:Such as child labor, forced labor, double books, and other 'zero tolerance' issues.
- Warn of Major Defects:Such as excessive working hours, insufficient social security, and other systemic compliance risks.
| Clause | Finding Description | Severity |
|---|---|---|
| 4.1 | Found indicators of risk of child labor or forced labor. | CRITICAL |
| 5.2 | Weekly working hours exceeded 60h in peak season. | MAJOR |
| 7.1 | First aid kit items expired in Workshop A. | MINOR |
Unable to fix gaps independently after discovering them?
Diagnosis is only the first step. If you lack remediation experience, our expert team can step in and guide you hand-in-hand through the correction process.
Contact Our Experts for Full-Service ConsultingEnd-to-End Pharmaceutical Compliance Consulting: From DMF Filing to Regulatory Inspection
Navigating international pharmaceutical regulations requires specialized expertise. QTC Global's regulatory consulting team provides comprehensive support — from drug master file preparation to on-site inspection accompaniment — helping Chinese manufacturers achieve and maintain compliance with global standards.
Drug Master File (DMF/MF) Compilation & Filing
The Drug Master File is the core regulatory document for APIs entering international markets. We provide compilation and filing services for:
| Document Type | Target Market |
|---|---|
| CEP (Certificate of Suitability) | European Union |
| US DMF | US FDA |
| EDMF (European Drug Master File) | EMA / EU |
| Japan MF | PMDA Japan |
| Other Country DMFs | Global Markets |
Services include: Document architecture planning, CTD format compilation (Module 3), change management and annual updates, regulatory inquiry responses.
WHO APIMF & API Prequalification
For API suppliers targeting WHO procurement markets, we provide WHO APIMF compilation and submission, API Prequalification program application support, and liaison coordination with WHO inspection teams.
GMP Gap Analysis & Remediation Support
Before pursuing certification or facing regulatory inspection, our gap analysis helps you benchmark your current state against the target GMP standard, prioritize remediation items with resource allocation guidance, and develop realistic remediation timelines. We also provide hands-on support during remediation including SOP writing, staff training, and ongoing follow-up.
CAPA Plan Development & Consulting
Following a Warning Letter or FDA 483 observation report, a professional CAPA plan is critical for returning to compliance. We provide root cause analysis support, CAPA plan writing and review, effectiveness verification planning, and regulatory response letter drafting.
Site Master File (SMF) Consulting
Site Master File preparation per EU GMP and PIC/S requirements. We also review and update existing SMFs to ensure ongoing compliance.
Translation & Inspection Support
- Interpretation — On-site professional interpretation for FDA, EMA, WHO regulatory inspections
- Translation — GMP documents, SOPs, inspection reports (CN↔EN, CN↔FR bidirectional)
- Inspection Readiness Training — Prepare facility staff for regulatory inspection procedures
- GxP Compliance Consulting — Integrated GMP/GLP/GCP/GDP advisory services