We are a young team of risk assessors specialized in regulatory toxicology with 4 years of experience in deriving Permitted Daily Exposures (PDEs)/Acceptable Daily Exposure (ADEs) and Occupational Exposure Levels (OELs). Our work is fueled by a strong passion for toxicology. Our professional experience has focused primarily on establishing health-based exposure limits (HBELs) for drugs produced in shared facilities, as well as assessing the associated health risks for workers.

Our trainings comply with:

• Masterclass in Navigating PDE-based Cleaning Validation & Cross-Contamination Risks in Pharma
• Drugs toxicology from Post-Graduate Medical Education in “Clinical Pharmacy” and “Pharmaceutical Laboratory”
• Industrial toxicology and ecotoxicology from Post-Graduate Medical Education in “Pharmaceutical Industry and Cosmetics”
• ISO 10993: Biological Evaluation of Medical Devices
• ISO 14971: Medical devices – Application of risk management to medical devices
• ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use
• ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
• EMA/CHMP/CVMP/SWP/169430/2012 – Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Our Toxicology Team is members of SSFR organization which is affiliated with EUROTOX. The team includes certified pharmacists in Clinical Pharmacy and certified pharmacists in Pharmaceutical Laboratory.