We have worked with various pharmaceutical companies, SMEs and FTSE 250 companies. You can be completely confident and assured that we possess all the experience and knowledge of the working of the Quality Management System Environment ensuring compliance with GxP guidelines such as Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
Setax can provide interim support (ranging from 1 day to 12 weeks or more as per your requirements) for your QMS in the following areas:
- Prepare a project plan with a defined milestone to capture your key deliverables
- Contract Responsible Person Services
- Perform a gap analysis to assess your QMS status
- QA training (GMP and GDP)
- Support in obtaining GxP licence
- Assist in the preparation for regulatory inspections
- Writing /Reviewing standard operating procedures
- External audit of third party suppliers
- QA functions such as closing overdue deviations, change controls, CAPAs etc.
- Other QMS activities
Our consultants ensure they are kept up to date with current GxP regulations by attending the annual MHRA GMDP Conferences and participating in various QA forums on LinkedIn. Where applicable, we apply project management principles and tools to manage your projects.