GGCP Compliance and Quality Assurance

Experienced in biopharmaceutical, medical device, and diagnostic regulations, Technimates’s experienced staff of regulatory team and quality professionals offer time-tested solutions for companies of all sizes.

Non-compliance is an expense that no life science company can afford. FDA will review all records that are associated with how the clinical trial was conducted. FDA’s main goal is to protect the rights, safety and welfare of the subjects enrolled in FDA regulated clinical trials. FDA will ensure that the sponsor has a process of identifying and dealing with protocol deviations in real time during the conduct of a clinical trial.

We are often asked about which documents are most helpful in understanding and preparing for US FDA GCO inspections. – All these documents all have standardized numbers, just like company SOPs. If you put the number into the search box on the FDA web page, you will receive a list that will include the Compliance Programs you need. Key ones to retrieve are Compliance Programs 7348.810 (Sponsors, Monitors and CROs) and 7348.811 (Clinical Investigators). Pay special attention to Part III titled, Inspectional and Part V titled, Regulatory in these documents to learn what to expect during an FDA GCP inspection.

Please contact us more information and our GXP compliance team will help and guide you.