Quality assurance
Quality assurance
We are able to provide you with a full range of independent GxP Quality Assurance Auditing, Consulting and Training for Pharmaceutical, Biotechnology and Medical Device products according to your needs.
Our global field force ensures that there are enough staff members to get your auditing and consulting needs scheduled, conducted and reported on time and when you need them. Our leadership and project managers assure that your deliverables are there on time and of the highest quality, allowing you to get on with your own schedule.
With the help of our in-house knowledge and our partners, we can offer you high quality service and expertise from:
Good Clinical Practice
GCP Audits
- CRO &/or SMO Vendors
- Internal Systems (Clin-Ops, DM, MW, etc…)
- Specialty Service Providers (imaging, ECG, IRB/EC, etc…)
- Phase I clinical study audits, including BA/BE studies
- Phase II to IV clinical study
- Safety Systems & Vendors
- Document audits: protocols, ICF, IB, CRF, CSRs, submissions, etc…
- Clinical Database audits
- Data Management & Biostatistics audits
- IVRS audit
- Management of audit programs for Phase III studies and mega-trials
- Clinical trial supply service providers
- FDA and/or EMA Mock Inspections
- Trial master files (TMF) for regulatory submission
Good Laboratory Practices
Clinical/GcLP:
- Clinical Safety
- Biomarkers
- Genetics
- Pharmacokinetic
- Histopathology
- Bioequivalence
- Bioanalytical
- Immunology
Pre-Clinical/GLP:
- Toxicology
- Teratology
- Inhalational
- ELISA
- Radio-isotope
Good Clinical Lab Practices
Clinical/GcLP:
- Clinical Safety
- Biomarkers
- Genetics
- Pharmacokinetic
- Histopathology
- Bioequivalence
- Bioanalytical
- Immunology
Pre-Clinical/GLP:
- Toxicology
- Teratology
- Inhalational
- ELISA
- Radio-isotope
Good Pharmacovigilance Practices
Pharmacovigilance Audits
- Clinical Safety
- Post-Marketing Safety
- Internal Full PV & Drug Safety Systems
- Company Affiliates
- Vendors (US, EU, Japan, etc…)
- Marketing & License Partners
- Product Distributors & Warehousing
- Call Centers
- Document audits: PSURs, DSURs, Contracts & SDEA, RMPs, etc…
- Safety Database Validation
- Submissions & Approvals
- Translation Services
- PV Master Files
Computer System Validation Audits
GxP Audits, Training, Consulting
- FDA and/or EMA Mock Inspections
- Pre-Inspection Training
- Inspection Hosting – Consultancy
- Inspection Results Mitigation
- Risk Assessment (system wide)
- Regulatory Affairs Audits
- Computer Systems Validation Audits
- GAP Analyses & SOP Development
- GxP Training (basic or advanced)
- Quality Management Evaluation
- Due Diligence
- For-Cause (Fraud, Misconduct)
- Archive Facility Audits
- Temporary On-Site Auditor Placement
- Evaluation of Auditor Competency
- Auditor Training
Revizija dobre prakse, usposabljanja, svetovanje
- Pregled modelov inšpekcijskih nadzorov Ameriške agencije za hrano in zdravila (FDA) in/ali Evropske agencije za zdravila (EMA),
- Usposabljanje pred inšpekcijskim nadzorom,
- Gostovanje inšpekcijskega nadzora in svetovanje v času nadzora,
- Omilitve rezultatov pregleda,
- Ocena tveganja (celotnega sistema),
- Nadzori regulatornih zadev,
- Revizije validacije računalniškega sistema,
- Analiza GAP in razvoj standardnih operativnih postopkov delovanja (SOP),
- Usposabljanja za dobro prakso (osnovno in napredno),
- Ocene kakovosti,
- Ocena poslovanja za vzroke goljufije, prevare,
- Revizija zmogljivosti arhiva,
- Začasna namestitev nadzornika,
- Ocenjevanje usposobljenosti nadzornika
- Usposabljanje nadzornika.
