Preclinical Testing

Toxicity-Testing- Pathology-Pharmaceuticals-Toxicological-Assessment

Each industry has specific considerations and requirements for toxicity studies based on the nature of the products and the associated regulatory requirements. Notably, SciQra does not conduct these studies in-house, but we rather assist our clients in determining their study needs, facilitate study placements with trusted CROs, and provide coordination, monitoring, and interpretation of study results.

Pharmaceutical Industry:

  • Facilitating nonclinical safety assessment strategies in therapeutic areas such as oncology, cardiovascular and metabolic disorders

  • Assisting in the development of safety-related issue mitigation and resolution plans

  • Determining the need for specific toxicology studies and facilitating study placements

  • Coordinating protocol development, finalizing study design, and study monitoring

  • Providing expert interpretation and analysis of study results for regulatory submission purposes

  • Preparing Pre-IND Briefing Packets and preclinical documents for regulatory submission

  • Assisting in the determination of the maximum recommended starting dose (MRSD)

Medical Devices Industry:

  • Determining the necessary biocompatibility and toxicity studies for medical devices

  • Facilitating study placements with CROs specializing in biocompatibility evaluations, including extractable and leachable studies

  • Assisting in the data interpretation

Chemical Industry:

  • Identifying the necessary in vitro and in vivo toxicology studies for chemical substances based on regulatory requirements (such as REACH)

  • Facilitating study placements with CROs specializing in acute, subchronic, and chronic toxicity evaluations

  • Coordinating and monitoring genotoxicity studies to assess the potential genetic effects of chemicals

  • Providing guidance on reproductive and developmental toxicity studies for assessing effects on fertility and fetal development

  • Assisting in the design and data interpretation

  • Facilitating ecotoxicity studies to assess the impact of chemicals on the environment and non-human organisms

Cosmetics and Household Products Industry:

  • Consulting on safety assessments of cosmetic and personal care products, including the need for specific toxicology studies

  • Facilitating study placements (in vitro) with CROs specializing in skin irritation, sensitization, and eye irritation evaluations

  • Coordinating dermal penetration studies to evaluate the absorption of substances through the skin

  • Facilitating ecotoxicity studies to assess the environmental impact of product ingredients

Frequently Asked Questions

  • Preclinical testing evaluates a candidate product’s safety, efficacy, and pharmacokinetics before human trials. It identifies potential toxicities, establishes safe dosage ranges, and provides the scientific foundation to proceed confidently to clinical development.

  • Early identification of toxicity, formulation challenges, or dosing issues helps minimize late-stage failures, reduce costs, and ensure safer progression into human studies. Preclinical data complements human-relevant models for accurate risk assessment.

  • Strategically designed preclinical studies highlight promising candidates, optimize dosing, and flag safety concerns early, thereby shortening development timelines and streamlining the path to first-in-human trials.

  • By modeling effects in sensitive populations (such as children) preclinical studies guide safe dosing and mitigate risks, supporting tailored clinical trial design.

  • SciQra advises on study selection, design, and regulatory alignment, facilitates CRO partnerships, coordinates protocols, monitors progress, and interprets results. Our expertise spans pharmaceuticals, medical devices, chemicals, and cosmetics—ensuring scientifically robust, compliant, and efficient preclinical strategies for successful submissions.