• Based on the fact that the manufacturing of Stem Cells must be performed at GMP compliant sites, we support our customers with our technical team in the design and construction of facilities in concordance with the expectations and requests of authorities and current GMP guidelines and directives.

 

  • While assessing a GMP compliant area, we provide our services by evaluating clean room, air locks and biosafety requirements with a risk-oriented integral concept approach.

 

  • By recognizing high risk and low risk operations in stem cell manufacturing areas, we determine necessary areas for classification.

 

  • In order to monitor airborne contaminants, temperature, relative humidity, differential pressure, etc. equipped with real-time controls and recording systems which constitute a GMP requirement, risks are evaluated in advanced as per ICH Q9 guidelines and other current GMP guidelines and directives.

 

  • A thorough assessment of staff, materials, equipment, raw material requirements are established with thorough and meticulous details.

You can sign up for our mailing list here: