BIOTEM is certified ISO 9001:2015 for the Quality Management System within the framework of its services activities

  • Custom antibody development (Research, Diagnostics, Therapeutics)
  • Antibody production (in vitro, in vivo, transient transfection)
  • Antibody purification and modification
  • Cell culture, immunohistochemistry and molecular biology

Certificate here

 

The company is also certified ISO 13485:2012 for its activities in the development, manufacturing and marketing of immunoassays for in vitro diagnostic use

  • Components analysis and selection
  • Prototype development
  • Immunoassay validation
  • Medical IVD device production and vigilance system

 

These certifications are the acknowledgement of the efficiency of BIOTEM’s quality assurance system and demonstrate a constant commitment of every employee to continual improvement process. They also act as guarantor that BIOTEM will conti-     nue responding to its clients’ demands by:

  • Complying with ethics and regulations
  • Carrying out quality controls on delivered products
  • Ensuring the safety of production means and devices
  • Performing risk analyses
  • Ensuring optimal project management
  • Respecting delivery deadlines

Certificate here