Toxicology

Secure your product development and accelerate your time-to-market with expert toxicological assessments tailored to the highest global regulatory standards. From impurity qualification to complex risk assessments, our experts provide the scientific clarity needed to overcome critical regulatory hurdles.

A single unforeseen toxicological risk can permanently stall your product’s journey.

The path from early discovery to market approval is increasingly complex. Life sciences companies must constantly adapt to evolving global standards, from REACH and ICH guidelines to specific cosmetic and food safety regulations. Effectively evaluating hazards, qualifying impurities, and managing non-clinical safety data requires not just deep scientific expertise, but also strategic agility to avoid costly development delays and protect public health.

Strategic toxicological expertise for your product life cycle

Secure your product development and accelerate your time-to-market with expert toxicological assessments tailored to the highest global regulatory standards. Aixial Group brings together senior toxicologists and regulatory strategists to transform your non-clinical data into robust, audit-proof safety profiles.

Our core expertise in toxicology

Aggregate exposure & risk assessment

Like our experts who publish advanced methodologies on consumer exposure habits, we don’t just look at ingredients in isolation. We evaluate the real-world, cumulative exposure of substances to build highly accurate safety profiles.

Impurity qualification & toxicological thresholds

Identification and qualification of impurities, degradants, and extractables/leachables (E&L) in strict compliance with ICH Q3A/B and M7 guidelines.

Multi-sector risk characterization

From early-stage pharmaceutical discovery to the complex risk characterisation required for Medical Devices, Cosmetics, and Food/Nutrivigilance.

Regulatory roadmaps & dossier preparation

Strategic drafting of non-clinical overviews (CTD Module 4), safety reports, and regulatory responses to overcome critical hurdles with the EMA, FDA, and other global authorities.

Looking for toxicology expertise to accelerate your product development?

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Working as a toxicologist in the pharmaceutical industry allows me to contribute to ensuring that patients around the world have access to safe medicines.

Jules Morsch

Toxicologist at Aixial

Tailored collaboration models

Functional service provision

We have extensive experience in governance, management, and partnership as an FSP provider. Our approach is tailored to your requirements and adapts as the partnership evolves.

Consulting support

We provide the clinical development capabilities and integrated consulting expertise needed to streamline development at every step, in a faster and more cost-effective way.

Full-Service CRO

Aixial Group is a well-established, full-service CRO with experienced people and advanced technology for clinical data management.

Q&A

What types of toxicology activities does Aixial Group support?

Aixial Group supports a wide range of toxicology activities, including preclinical and clinical toxicology, safety assessment, risk evaluation, and regulatory toxicology. Our experts contribute across all development phases to ensure product safety and compliance.

What operational models do you offer ?

To match your internal infrastructure and budget, we offer three flexible delivery models:

Functional Service Provision (FSP): Dedicated experts seamlessly integrated into your teams.

Consulting & operational support: Ad-hoc expert guidance, data entry management, and clinical site training.

Full-Service CRO partnership: Managing your clinical trial end-to-end with our teams, technology, and project governance.

What industries do your toxicology teams work in?

Our teams work across several industries, including pharmaceuticals, biotechnology, medical devices, cosmetics, and chemicals.

How does Aixial Group ensure global regulatory compliance?

We strictly align our processes with ICH, EMA, and FDA guidelines, maintaining an industry-leading record of 100% on-time safety reporting. Our safety experts and medical reviewers continuously monitor regulatory updates to guarantee that your clinical trials and commercial products remain fully compliant.

Where are toxicology positions based?

Positions are available in several locations depending on project needs, including on-site with clients, or in flexible working arrangements.