Mae Ann Belandres

ERT (EUROTOX Registered Toxicologist) · Senior Consultant Toxicology

Mae Ann is a Senior Toxicology Consultant at QbD Group, providing expert nonclinical safety assessments and regulatory toxicology guidance for pharmaceutical and biotech companies.

6 articles

Quality Assurance14 nov 2025 3 min

Cómo preparar una ERA lista para su presentación

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Quality Assurance7 nov 2025 3 min

How to Prepare a Submission-Ready Environmental Risk Assessment (ERA)

Learn how to prepare a compliant, submission-ready Environmental Risk Assessment (ERA) under the 2024 EMA guideline, with tips for data, logic, and reporting.

Regulatory Affairs6 oct 2025 4 min

Environmental Risk Assessment (ERA) in Drug Products: Understanding the EMA Guideline

Learn how the EMA guideline defines Environmental Risk Assessment (ERA) for drug products, including its structure, key phases, and implications for pharmaceutical development.

Regulatory Affairs29 jul 2025 5 min

Evaluación del Riesgo Ambiental (ERA) en medicamentos

Descubre cómo la guía de la EMA define la Evaluación de Riesgo Ambiental (ERA) para productos farmacéuticos, incluyendo su estructura, fases clave e implicaciones para el desarrollo farmacéutico.

Quality Assurance14 mar 2025 5 min

Información sobre el registro REACH de sustancias químicas en el sector farmacéutico

REACH registration is more than just a regulatory box to check — it's a crucial step for companies in the pharma, life sciences, and chemical industries manufacturing or importing substances into the EU. This blog post walks you through what REACH entails, why it matters, and how to ensure smooth...

Toxicology4 feb 2025 4 min

Understanding REACH Registration for Chemicals in Pharma

Discover how pharma and life sciences companies can navigate REACH registration to achieve compliance with EU chemical regulations. Read more!

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