Quality Assurance affects every aspect of the drug development and commercialization process ensuring compliance with legislation and internal standards during every step along the way. We can provide the additional support needed wherever help is required by using subject matter experts relevant to the particular aspect of your system under review.
Standard Operating Procedures (SOPs) are a cornerstone in any Quality Management System (QMS). We can perform a gap analysis to determine SOPs needed or SOPs to be further developed and assist in the preparation of these SOPs; from a full suite to a one-off procedural document.
Auditing is a necessary mechanism for management assurance of quality. We can help in the development of your audit program and conduct internal audits, Investigator site audits and vendor audits on your behalf.
The QMS is more than a suite of SOPs and audits. Training and its documentation, SOP deviations, Corrective and Preventative Actions (CAPA), continuous SOP improvement must all be managed; we can help in establishment and maintenance of your QMS.
Finally, we can be there to help you through Regulatory Inspections; from preparation, running the QA back-office for the Inspection days and forming responses and CAPA.
Our subject matter experts take a systems approach to work with you to develop better internal practices and systems.
Summary of Services:
- QMS Development
- SOP Development
- Gap Analysis
- Inspection Readiness and Support
- Audits: Internal, Investigator Site and Vendor