Our Quality Management services are designed to ensure that our clients' products, processes, and facilities consistently comply with cGMP and applicable global regulatory requirements. We support the establishment and maintenance of a robust, inspection-ready Quality Management System (QMS) that embeds quality oversight, regulatory compliance, and a proactive quality culture across the organisation. Our Quality Management services include, but are not limited to:
Our Quality Management Services
- Vendor Audits
- Mock FDA/TGA/EMA Audits
- Internal Audits
- Risk Management
- Supplier Qualification and Management
- Inspection Readiness Plan and Audit Response Compilation
- Quality System Development and Implementation
- Paper-based to eQMS Migration
- Critical investigation management and root cause analysis
- Facility validation and qualification
- FDA Warning Letter (WL) Remediation
150+ GMP and quality audits in the following jurisdictions
Our Experience & Expertise
Extensive Audit Portfolio
We have performed more than 150 GMP audits including vendor audits, mock GMP inspections, due diligence audits, and routine internal audits for our clients across various jurisdictions and dosage forms.
Regulatory Inspection Success
We have successfully prepared various GMP facilities around the world for EMA, FDA and TGA Pre Approval Inspections (PAIs) and supported our clients in obtaining GMP approvals.
Risk Assessment Excellence
We support clients in product, facility and process risk assessment using techniques such as FMEA, Fault tree analysis, and formal Brainstorming.