Quality Management Services

Our quality management services ensure that our client's products and facilities meet cGMP and regulatory requirements. Our quality management services include, but not limited to:

• Vendor Audits
• Mock FDA/TGA/EMA audits
• Internal Audits
• FDA Warning Letter (WL) remediation
• Risk Management

We have performed more than 40 GMP audits including vendor audits, mock GMP inspections, due diligence audits, and routine internal audits for our clients. These audits are performed in various jurisdictions such as Australia, United States, Europe (including Italy, France, Sweden, United Kingdom etc). Our experience extends across drug substance and drug product manufacturing, including injectable, semisolid, liquid, and solid dosage forms.

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 and product Marketing Authorisations (MAs).

We also support our clients in product, facility and process risk assessment using techniques such as FMEA, Fault tree analysis, and formal Brainstorming.