Toxicology Consulting
Aclairo has decades of experience providing toxicology services to our many clients with a proven track record of regulatory success in a cost and time efficient manner across a wide variety of modalities and indications.
Toxicology Consulting for Drug Development
Toxicology consulting helps sponsors determine potential safety concerns of their drug and/or target and place those risks into perspective. To characterize those potential risks, we support the design, conduct, and interpretation of nonclinical studies required for drug development and regulatory submission. Aclairo provides toxicology consulting services to help organizations develop effective strategies, execute studies, and prepare for successful global regulatory interactions.
Our consultants bring experience from pharmaceutical companies, contract research organizations, FDA, and academia, allowing us to guide programs from early development through IND-enabling studies and throughout its life cycle.
When is Toxicology Consulting Needed?
- Designing toxicology strategies for IND or global regulatory submissions
- Addressing complex safety or regulatory challenges
- Preparing for Health Authority interactions (e.g., FDA meetings)
- Conducting due diligence or gap analyses of existing programs
- Supporting manufacturing safety assessments (PDE/ADE/OEL)
- Nonclinical investigation of clinical adverse events
- Integrating pharmacology and safety pharmacology data
- Evaluating product quality (impurities, leachables, excipients)
Expertise in Toxicology
Our consultants have extensive experience in small and large pharmaceutical companies, contract research organizations, FDA, and academia. We can help you design, conduct, monitor, edit, and report your toxicology studies to prepare you for global regulatory success.
With expertise in safety pharmacology, phototoxicity, genetic toxicology, general toxicology, carcinogenicity, developmental and reproductive toxicology, and juvenile toxicology, we provide comprehensive nonclinical support for your therapeutic.
Aclairo consultants routinely help clients with:- Acting as the toxicology project team representative or team leader
- Providing strategic and scientific advice
- Minimizing animal use in toxicology programs by incorporating appropriate in vitro methods
- Authoring or editing regulatory submissions
- Designing and implementing overall toxicology strategy
- Due diligence and gap analyses
- Preparation and attendance for Health Authority meetings
- In silico genetic toxicology assessments
- Program management for nonclinical studies
- Nonclinical study monitoring
- Study placement
- Study report refinement
- Lab qualification site visits
- Aid the integration of in vitro and in vivo pharmacology and safety pharmacology and/or abuse liability
- Facilitate product quality assessments (impurities, leachables, excipients) and ADE/OEL to support manufacturing
Related Services
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Frequently Asked Questions
- What toxicology studies are required for an IND? It depends on multiple factors including drug target and modality along with proposed clinical plan. Aclairo consultants can design a program to successfully navigate regulatory expectations.
- What is the role of toxicology in drug development? A critical component of any drug approval is a thorough evaluation of both on- and off- target toxicity of the therapeutic.
- How can animal use be minimized in toxicology programs? Our consultants can streamline study designs to minimize animal use while maintaining scientific validity and regulatory compliance. We are staying current with the latest regulatory acceptability of new approach methodologies (NAMs).
- What is genetic toxicology and when is it required? Genetic toxicology involves understanding the in vitro and in vivo impact of a therapeutic on DNA. Depending on the therapeutic modality and indication, testing is frequently required, and we can help you determine the right path.
- How do regulatory agencies evaluate toxicology data? Regulators look carefully at all data, including the individual animal data to understand the potential toxicities of a therapeutic. This is a rigorous process, and having the appropriate expertise and experience to understand your toxicology data prior to filing is fundamental to approval.
- What is the difference between GLP and non-GLP toxicology studies? Typically non-GLP toxicology studies use fewer animals, and do not undergo a quality assurance review of the data and report.