Pharmaceuticals – Risk Assessment

Expert assessment to ensure product safety

Customised toxicological risk assessments to support compliance and development decisions.

Comprehensive Toxicological Assessments

We provide expert safety assessments for excipients, including exposure scenarios, Margin of Safety (MoS) calculations, suggested dosage adjustments and local tolerance assessments at contact sites.
We also assess process impurities and contaminants, including Nitrosamines, to support qualification strategies that meet current regulatory expectations

Facility & Worker Safety Risk Evaluations

Our team conducts PDE (Permissible Daily Exposure) and OEL (Occupational Exposure Limits) assessments for human pharmaceuticals, including:

Common production facilities
Occupational safety in environments where active pharmaceutical ingredients (APIs) and intermediates (IPIs) are handled.

These assessments comply with EMA and ICH guidelines.

Advanced In Silico & E&L Assessments

We provide QSAR modelling, read-across justification and analogue identification for poor data substances in accordance with ICHM7 and ECHA guidelines.

In addition, we perform Extractables & Leachables (E&L) risk assessments to ensure material compatibility and product safety of packaging and delivery systems.

Advantages for the customers:

Reliable toxicological data to support formulation, manufacturing and regulatory compliance
Expert PDE and OEL assessments to avoid cross-contamination and risks in the workplace
In silico strategies to reduce testing burden for substances with limited data
Risk assessments in line with EMA, ICH and ECHA standards
Faster decision-making through clear, science-based safety justifications

Why Choose CRONET?

Completeness

All your preclinical needs covered in one place

Expert Guidance

A team of dedicated experts focused on your success

Innovation

Access to cutting-edge techniques and multidisciplinary services

Efficiency

Optimized costs, timelines, and study quality