QUALITY GUIDANCE

Expert Guidance Every Step of the Way

Our consultants have strong experience in quality aspect of biopharmaceutical industry.  Our approach is to have robust, quality minded decisions and documentation to ensure that your company will provide products that are safe and effective, and to deliver with optimal use  to your patients.  Here are some of the following areas of expertise:

• Review of standard procedures and high-level quality documents

• Corrective and Preventative Actions (CAPAs)

• Management of the discrepancy management systems (DMS)

• Change Control systems

• Gap Analysis and Remediation

• MDR and Complaints

• NCMR Review

• Auditing / Internal Audits