The ICH Q3D guideline aims to limit the presence of potentially toxic elemental impurities in medicinal products.
Issuing of the elemental impurities risk assessment
Download a sample risk assessment here for free
Do you already know how to proceed after having obtained an Elemental Impurities risk assessment?
Due to the individual specifications of medicinal products, we cannot offer a fixed price for these risk assessments. It also depends on whether available data only needs to be screened or whether a validation and risk analysis have to be conducted. We will be pleased to send you a binding, fixed price quote after verifying the critical key data.
Our customers say:
"... many thanks for the professional support in this matter"
"... we appreciate the constructive collaboration with the colleagues from Azierta very much"
"... summarised very nicely"
"... we will be happy to come back to you in comparable situations"
"... worked out perfectly"
Cynthia Schulz
Phone: +49 7622 6668670
E-Mail: cynthia.schulz@gmp-verlag.de