Quality

We offer a range of CMC advisory services to support the development of your products, from Pre-clinical to Phase III, taking into account FDA, EMA and other regulatory guidance. Our CMC advisory services include the following:

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

Vendor Audits: Our team has extensive experience auditing API and drug product manufacturing facilities, including injectable, semisolid, liquid and solid dosage forms. We support our clients in Vendor Program Management and Inspection Readiness.

Mock FDA/TGA/EMA audits: We provide comprehensive mock audit services to help our clients prepare for regulatory inspections. Our team of experienced lead auditors identify the deficiencies in the quality assurance and manufacturing system and help remediate these findings before the regulatory inspectors arrive.

Internal audits: Many companies find it challenging to perform internal audits in a timely manner due to a busy environment or lack of resources. Our team, with relevant industry experience, can assist you in performing internal audits, identifying nonconformances and gaps, and supporting continuous improvement.

FDA Warning Letter (WL) remediation: Responding to FDA WL is a considerable challenge for a company as it requires the deployment of massive resources and expertise. We have helped various organisations successfully remediate FDA Warning Letters, avoiding enforcement actions and ensuring the continuity of their product supply. We provide an independent assessment of the deficient system, detailed CAPA and remediation plan.

Quality Risk Management: We provide Quality Risk Management services to help you identify, assess, and mitigate risks associated with processes, facilities and new product development.