Toxicology Services for Safety and Risk Assessment
LINK Medical offers expert guidance in designing toxicology programs that meet scientific rigor and regulatory expectations. We also provide biological evaluations for medical devices in accordance with applicable regulatory requirements.
Fit-for-purpose toxicology strategy
The regulatory guidelines within toxicology are designed to guide product developers toward safe and compliant outcomes. We provide the expertise to understand when the guidelines allow for flexibility, scientific justification, or alternative approaches that are both valid and acceptable. A bespoke strategy for each drug project will save time, resources, and avoid unnecessary testing.
Experienced toxicologist guidance
Our experienced toxicologists contribute actively to regulatory interactions, including scientific advice meetings with authorities, and support the preparation of essential documents for regulatory submissions. In addition, we prepare safety evaluations and risk assessment documents for drug substances, impurities, and other relevant aspects of drug development.
From Study Design to Data Evaluation
LINK Medical will support you in the selection of CRO for your studies, the study design, route of administration, appropriate species, dose levels and formulations, and preparation of study protocols/plans.
We act as study monitors and toxicology experts in the implementation, conduct, evaluation, and reporting toxicity and safety pharmacology studies, both GLP and exploratory studies.
Toxicological safety assessments
Safety assessment of possible adverse effects observed in nonclinical studies is essential to ensure safety for clinical use of a drug. By interpreting toxicology data together with toxicokinetic and safety pharmacology results, LINK Medical can help translate nonclinical findings into a reliable assessment of human risk. This understanding forms the basis for defining safe starting doses in humans and identifying potential hazards.
Toxicology provides information on potential adverse effects, their severity and reversibility, and the exposure levels at which they occur.
Toxicokinetics shows how the compound behaves in the body – how it is absorbed, distributed, metabolized, and eliminated. This allows us to place toxicological findings in a meaningful context and ensures nonclinical exposure levels are relevant for clinical studies.
Safety pharmacology evaluates the potential effects on vital physiological functions, including the cardiovascular, respiratory, and central nervous system.
By combining these disciplines, we take a structured approach to risk assessment that supports well reasoned decisions and responsible progression into clinical trials, in alignment with regulatory expectations (EMA/FDA).