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.
Environmental Risk Assessment: ERA reports
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.
Expert toxicology evaluation report
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.