As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities.
As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated.
The ICH Q3D guideline aims to limit the presence of potentially toxic elemental impurities in medicinal products.
The proven and successful collaboration between Azierta and GMP-Verlag provides you with an economically priced alternative to conventional elemental impurities risk assessments.
Issuing of the elemental impurities risk assessment
Do you already know how to proceed after having obtained an Elemental Impurities risk assessment?
Contractor in accordance with EU GMP Guide Chapter 7: Azierta Contract Scientific Support Consulting S.L., Vía de las Dos Castillas 33, Edificio 7-h,
28224 Pozuelo de Alarcón (Madrid), Spain
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 partner Azierta is the market leader in Spain for the preparation of toxicological assessments and employs approximately 15 toxicologists for the preparation of PDE reports, OEL categorisations or elemental impurities risk assessments. These are also successfully used by the industry in other European countries (e.g. Germany, Switzerland, Italy, Belgium) and have been accepted by the authorities.
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"