• Azierta is a European scientific reference company in developing  PDE/ADE reports.

• Now you can request your PDE reports online (Permitted Daily Exposure) for any custom API.

• At Azierta, we guarantee the health and safety of the staff involved in pharmaceutical manufacturing processes.

• We are experts in occupational exposure limits (OEL), categorization of APIs and health surveillance protocols.

Browse available OELs

• Specialized environmental toxicologists with wide experience in new drug registrations develop ERA reports for the assessment and analysis of API effects on the environment.

• Evaluation procedures are based on the latest EU guide: EMEA/CHMP/SWP/4447/00 and the Risk assessment for each API is performed using the most updated IQVIA data base.

• 2.4 & 2.5 Module: Support in the elaboration of reports to be submitted in the application for registration of medicinal products demonstrating safety and pharmacological efficacy under the applied conditions of use, respectively.

• According to ISO 10993-1:2018, the Biological evaluation of medical devices has to be provided as part of the information needed to register a Medical Device.

• Risk Benefit Medical Device: at Azierta, we provide comprehensive support covering the biocompatibility evaluation, evaluation of test results when necessary, the risk assessment report of medical devices and its regulatory management.

• At Azierta we have a multidisciplinary team, our toxicological experts and regulatory team can support you in all the stages of the registration of a Medical Device.