QUALITY IS CONTINUAL IMPROVEMENT

The entire area of quality management—including quality planning, quality control and quality assurance—makes an important contribution to improving your efficiency. Here, we offer consulting, preparation, implementation and maintenance of QM systems in the fields of GCP, GLP, GMP/GDP and GVP according to the following standards: 

• GCP (Good Clinical Practice as defined by the Directives ICH-GCP E6 (R2))
• GLP (Good Laboratory Practice as defined by the OECD Principles of Good Laboratory Practice)
• GMP (Good Manufacturing Practice as defined by the EU GMP Guidelines, USA cGMP Regulations, ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
• GDP (Good Distribution Practice as defined by the EU GDP Guidelines)
• ISO 9001:2015 (Quality Management Systems - Requirements)
• ISO 13485:2016 (Medical devices - Quality Management Systems - Requirements for regulatory purposes) and ISO 14971:2007 (Medical devices – Application of risk management to medical devices)
• Pharmacovigilance, GVP (Good Pharmacovigilance Practices as defined by the EU GVP Guidelines and local regulations)
  
  

Our support is used by pharmaceutical/biotech companies, healthcare institutions, University clinics and hospitals, medical care centers and resident physicians.