GxP Quality Services was founded in 2024 to support the companies in the clinical development of their Investigational Medicinal Products (IMP) until their registration as well as in the maintenance and supervision of their PharmacoVigilance (PV) Quality System covering their marketed products.
Core business
AUDITING SERVICES
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- GCP Audits : Investigator Site Audit, Phase I center Audit, Clinical Study Report Audit, Data Monitoring Committee Audit, Trial Master Files Audit, System Audit
- GLP Audits : System
- GMP Audits : Manufacturer of Investigational Products, Distributors
- Pharmacovigilance Audits : Affiliates, Partners, System, Service Provider or Supplier
- Qualification/Follow-up Audits of Service Provider, Supplier
QUALITY MANAGEMENT SYSTEM (QMS)
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- Building a flexible & an efficient QMS : process/system development
- Management or supporting the management of Quality events
- Audit Program preparation : collection of data and risk analysis
- Audit program development : Annual Audit Program, Clinical Study Audit program, Annual or Strategic PV Audit Program
- Pharmacovigilance System Master Files (PSMF) : development and maintenance
- Product Specification File (PSF) : development and maintenance
TRAINING
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- Audit techniques
- Data integrity
- Inspection behavior : on-site and/or remote inspection considering the agency’ specificities (e.g., ANVISA, EMA, MHRA, PMDA, US FDA)
- Process writing
- On-demand
INSPECTION READINESS PROGRAM
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- Gap analysis and mitigation plan
- Inspection tools : Development and set-up
- Mock Inspection : GCP Inspection (US FDA, EMA, PMDA and other agencies), PV Inspection (US FDA, EMA, MHRA and other agencies), CMC Inspection (PMDA)
DUE DILIGENCE ACTIVITIES
- Assessment of the dossier before acquisition of the product/programme
- Assessment of partner’s quality system before commercial agreement
News
Interactions with Universities/Masterclass
GxP Quality Services is involved in dispensing courses at different universities/school in Europe.
Contact us
Any question or any need you may have please contact us by completing the form below.
