We work to the highest quality requirements across numerous GXP and ISO standards for Medicinal and Medical Device clinical trials.
Our Quality Management System (QMS) includes:
- Annual risk-based internal audit program
- Risk-based vendor assessment and management
- Incident/complaint management
- Validated computerised systems used in clinical trials
We can be called upon for review of a single SOP or for setting up a complete quality system.
We have specialised professionals with broad experience from quality assurance, quality control and quality advisor positions with health authorities and the international pharmaceutical industry.
Our expertise can be called upon for review of a single SOP or for setting up a complete quality system. Our services can be used in-house or at the customer’s premises, with subcontractors, or we can take care of specific parts of a company’s processes. Let us advise you on the appropriate quality level of your operation.
Services within Quality assurance:
Audit services for:
- Investigational sites
- Clinical and analytical laboratories
- Manufacturing, packaging and distribution
- Phase I Units
- GCP, GLP and GDP compliance
QA of study deliverables including:
- Case report forms (CRFs & eCRFs)
- Clinical study reports
- Statistical analysis plans (SAPs)
- Tables and listings
- Study files (at a site and in-house)
Other QA services:
- Regulatory inspection readiness and response
- Pre-audits and -inspections
- Training to prepare investigational sites for regulatory inspections
- Training in GCP, GDP, GVP, IMP handling and Quality management
- Developing and implementing quality systems in small pharmaceutical, biotech and medical device companies