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PDE & HBEL Reports

Our highly specialized multidisciplinary team prepares PDE/ADE (Permitted Daily Exposure) reports for any API according to the EMA directive for the pharma and vet industry.

Toxicological Evaluation of impurities & Risk Analysis

Through our spececialized area in toxicology, we provide a comprehensive service covering all the necessary steps for the identification and analysis of Impurities

PSUR Medical Devices

Azierta Care supports manufacturers in the preparation of Periodic Safety Update Report (PSUR), as we have a team of professionals with extensive experience in Medical Devices.

About Us

 

Azierta is a Global Life Sciences & Health Consulting focused on providing services in Pharmacovigilance, GxP Compliance & Safety, Regulatory Affairs, Healthcare, Audits & Certification, Digital, Science & Growth, Health Management & Facilities and Life Sciences.

Under the slogan “Science to business” we accompany the Life Sciences industry in its development, transformation and the comprehensive management of the life cycle of its products and services.

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- News & Events -

Blog

Main Changes revision ICH Q3D (R2) on elemental impurities guideline

Blog

Inorganic impurities

Blog

Manufacture of Sterile Medicinal Products Key criteria to be considered

Through our offices & partnership network,
we provide Life Sciences & Health support worldwide.

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