Each industry has specific considerations and requirements for toxicity studies based on the nature of the products and the associated regulatory requirements. Notably, Scipex 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