Services
Mirabilitas Ltd offer a range of GXP Quality Assurance and Training Services
GCP Services
- Process evaluation, gap analysis and improvement services
- GCP guidance & advice including CAPA and issue resolution
- Contract Research Organisation (CRO) / Vendor audits (including archives)
- GCP system & process audits
- Phase I study, facility and systems review
- Quality Management Systems – strategy advice & support
- Study documentation and in-life audits
- Clinical Laboratory – see Clinical Laboratory Services
GLP Services
- GLP guidance & advice
- Process evaluation, gap analysis and improvement services
- GLP system, process and facility audits
- Study documentation and in-life/critical phase audits
- Contract Research Organisation (CRO) / Vendor audits
- Quality Management System strategy advice
- Independent Quality Assurance Audits (Audits of QA)
- Archive audits
Clinical Laboratory Services
- Clinical laboratory audits: bioanalysis, pharmacokinetic analysis, endpoint analysis, central laboratories, academic and research laboratories
- Quality Management System – strategy advice & support
- Study documentation and in-life audits
- Process evaluation, gap analysis and improvement services
Mock Inspections
- Inspection training (including practical workshops)
- Pre- and post- inspection advice
- On-site and remote mock inspection services
- Effective inspection preparation
- Inspection interview practice
- End-to-end inspection process rehearsals: pre-inspection document submissions, interviews, system demonstration, document review, reports & responses
- Inspection response review
- Targeted preparation for those tricky explanations
Pharmacovigilance/GVP Services
- Process evaluation, gap analysis and improvement services
- GVP system & process audits
- Contract Research Organisation (CRO) / Vendor / Service Provider audits
- Local Operating Company / Affiliate audits
- Marketing Authorisation Holder (MAH) audits
Training & Mentoring
Looking for something lively and flamboyant? Look no further than our training and mentoring services…
- Introductory, intermediate, and advanced training for auditors
- GCP, GLP and Pharmacovigilance Training
- Bespoke GXP Training
- Data Integrity Training
- On-the-job auditor coaching & mentoring