At PRETOX CONSULTANCY (PTC), we specialize in comprehensive toxicological risk assessments to ensure product safety and regulatory compliance. Our experts evaluate impurities, active substances, excipients, and medical devices following international guidelines (ICH, EMA, OECD, ISO). 

We provide detailed reports and scientific justifications to support regulatory submissions and development decisions.

Our Expertise Includes:

1. Permissible Daily Exposure (PDE) levels to address cross-contamination in shared facilities for active pharmaceutical ingredients  and pharmaceutical intermediates. 

2. Occupational Exposure Limits (OEL/OEB) for active pharmaceutical ingredients (API) and pharmaceutical intermediates in the work environment.

3. Conduct toxicological risk assessment reports (PDE/OEL) as expert in accordance with EMA/CHMP/ CVMP/ SWP/169430/2012. Expert in scientific literature search, extract, analyze and compilation of toxicologically relevant data including preparation of relevant toxicology summaries in support of toxicological risk assessment.

4. Working in hazard assessment, identification of critical effects, selection of suitable point of departure determination of the NOAEL of the findings that are considered to be critical effects, use of several adjustment factors (F1 to F6) to account for various uncertainties and finally derivation of health based exposure limits (PDE- Permitted Daily Exposure).

IMPURITIES:

(ICH) Q3A(R2), ICH Q3B(R2), ICHQ3C(R4) and VICH GL10 (R1) require that drug manufacturers identify, quantify and qualify real or potential impurities in drug substances and drug products.

Toxicity studies:
-> Genotoxicity studies (gene mutation and chromosomal damage tests)
-> Repeated dose toxicity study in one species of 14-90 days duration (depending on the proposed clinical dosage regimen).