Innoqua - Toxicology Consultants

VETERINARY MEDICINAL PRODUCTS

Nonclinical Development Programs

We prepare nonclinical programs tailored to the specific needs of your pharmaceutical or immunological veterinary products under development. We understand that every test substance has unique pharmacological properties and toxic class alerts and falls under the scope of different regulatory framework with regards to its chemical nature, origin or clinical indication. The strategic and financial circumstances of each sponsor are also unique. We therefore recognise that every nonclinical program needs to be adjusted to particular situations.

We also review your existing nonclinical program and advice on potential refining if needed.

Management and Monitoring of Nonclinical Studies

The management and monitoring activities that we offer to our customers include involvement on study design, selection of suitable CROs around the world (considering expertise, slots and prices), requests for cost estimates to CROs, definition and critical review of protocol to ensure regulatory compliance, management tasks, direct communication with study directors, follow-up / monitoring of all study activities, coordination of tasks in multisite studies, assistance on any decisions along the study, interpretation of study results and critical review of the study report.

Nonclinical Safety Studies in Target Species

We offer to our customers assistance with the study design, management and monitoring activities of nonclinical safety studies performed on target species.

Interpretation and assessment on nonclinical safety data

We help sponsors to identify critical issues with regards to the safety profile of pharmaceutical and immunological veterinary medicinal products, assess the relevance of data and the impact on viability of the project, and provide advice on follow-up studies to clarify toxicological findings.

Preparation of Regulatory Documentation

We prepare Nonclinical Overviews, safety assessment reports, expert reports and the nonclinical sections of regulatory documents according to Notice to Applicants recommendations.

Preparation of Scientific Advice

We provide assistance to pharmaceutical companies in the preparation of Scientific Advice requests to EMA or local agencies, identifying critical issues in the nonclinical development plan that require regulatory feedback and constructing the rationale for the company’s position.

Due Diligence

Innoqua can provide technical support during Due Diligence to identify critical issues, prepare and give adequate responses, and interpret data for either licensing in or licensing out purposes.

User Safety Assessments

We assist our customers with the evaluation of the potential risks that may result from the exposure of human beings to a pharmaceutical veterinary medicinal product. We also help to establish the special precautions which need to be taken by the person administering the medicinal product to animals, in order to reduce the risks to an acceptable level.

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To this end, we perform the exposure assessment, considering different relevant exposure scenarios and identify the potential hazards on the basis of appropriate toxicity tests regarding relevant endpoints for local and systemic toxicity.

We also perform risk characterization comparing the potential exposure level with the exposure levels at which no adverse effects are expected to occur, and give advice on risk management evaluating and recommending our customers on appropriate measures for risk reduction.

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Safety Studies for Veterinary Drug Residues

We assist our customers with toxicological evaluations to establish the safety of veterinary drug residues in human food.

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With this aim in mind, we support our customers on design, management and performance of toxicity and nonclinical studies needed to evaluate the safety of a veterinary drug substance in accordance with the VICH guidelines currently in place. We also identify the NOAEL for the veterinary drug and the determination of acceptable daily intakes (ADIs) for the veterinary drug residues in human food.

We also give support on the design, management and performance of studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animal’s, validation of analytical methods used in residue depletion studies, marker residue depletion studies to establish product withdrawal periods, and comparative metabolism studies in laboratory animals.

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