Our Core Competence - our Experience
Support of your Management - Consultancy
We support your management in Quality Assurance (QA), Research & Development (R&D) and Drug Safety (DS). The experiences of GQS since foundation in 1992 are summarised subsequently:
Quality by Business Consultancy
Use our expertise and ideas for organizing, optimizing, analysing, or changing your business processes by development and adjustment of
- Quality management systems
- Reference documents (Standard Operating Procedures, Working Instructions)
We prepare your company for regulatory inspections, setting up your start-up or subsidiary company.
Quality by interim management
Expand your creative potential and use our ideas for
- Staffing of management functions up to final recruitment of a position
- Deputizing management functions in case of loss or bridging during interim periods
- Quality related alignment of functions
- Outsourcing of quality management functions
Quality in Pharmacovigilance
Our Pharmacovigilance specialists expand your resources by independent planning, conduct, and reporting of audits concerning your
- Pharmacovigilance systems
- Contract research organisations (CRO)
- Co-operation / license partners
- Pharmacovigilance functional units in your affiliates
We prepare or revise your Pharmacovigilance relevant documents, such as
- Reference documents (Standard Operating Procedures, Working Instructions)
- PSMF, PSUR / PBRER
Quality in Clinical Research
Support your R&D staff by use of our specialists for an independent planning, conduct, and reporting of audits concerning your
- Systems
- Contract research organisations (CRO)
- Investigational sites
- Study documents such as protocol, CRF, reports, trial master file (TMF)
Use our expertise and ideas for organizing, optimizing, analysing, or changing your business processes by development and adjustment of
- Quality management systems
- Reference documents (Standard Operating Procedures, Working Instructions)
We prepare your company for regulatory inspections, setting up your start-up or subsidiary company.
Expand your creative potential and use our ideas for
- Staffing of management functions up to final recruitment of a position
- Deputizing management functions in case of loss or bridging during interim periods
- Quality related alignment of functions
- Outsourcing of quality management functions
Quality in Pharmacovigilance
Our Pharmacovigilance specialists expand your resources by independent planning, conduct, and reporting of audits concerning your
- Pharmacovigilance systems
- Contract research organisations (CRO)
- Co-operation / license partners
- Pharmacovigilance functional units in your affiliates
We prepare or revise your Pharmacovigilance relevant documents, such as
- Reference documents (Standard Operating Procedures, Working Instructions)
- PSMF, PSUR / PBRER
Quality in Clinical Research
Support your R&D staff by use of our specialists for an independent planning, conduct, and reporting of audits concerning your
- Systems
- Contract research organisations (CRO)
- Investigational sites
- Study documents such as protocol, CRF, reports, trial master file (TMF)
Our Pharmacovigilance specialists expand your resources by independent planning, conduct, and reporting of audits concerning your
- Pharmacovigilance systems
- Contract research organisations (CRO)
- Co-operation / license partners
- Pharmacovigilance functional units in your affiliates
We prepare or revise your Pharmacovigilance relevant documents, such as
- Reference documents (Standard Operating Procedures, Working Instructions)
- PSMF, PSUR / PBRER
Support your R&D staff by use of our specialists for an independent planning, conduct, and reporting of audits concerning your
- Systems
- Contract research organisations (CRO)
- Investigational sites
- Study documents such as protocol, CRF, reports, trial master file (TMF)