At PRETOX CONSULTANCY (PTC), we design and implement customized nonclinical development strategies to accelerate your product’s journey from concept to clinical stage. Our goal is to ensure scientific integrity, regulatory compliance, and cost-effective planning at every step.

We work closely with clients to develop study plans that meet the expectations of global health authorities such as USFDA, EMA, MHRA, and CDSCO.

Providing nonclinical support to integrated product development for IND, NDA, 505b2, ANDA application, and complex generics drug development.

The objectives of nonclinical development include:

• Safety Assessment: Ensuring the therapeutic does not pose undue risks to human subjects.
• Efficacy Evaluation: Demonstrating the potential therapeutic effect in relevant models.
• Pharmacokinetics and Pharmacodynamics: Understanding how the drug is absorbed, distributed, metabolized, and excreted.
• Toxicology Studies: Identifying potential toxic effects and establishing safe starting doses for clinical trials.

Key Considerations for a Successful Nonclinical Program

• Regulatory Compliance: Following guidelines established by agencies such as the FDA, EMA, NDCT rules ensures that nonclinical studies meet the required standards and expectations.
• Study Design and Model Selection: Choosing appropriate animal models and study designs that accurately reflect human biology is crucial for generating meaningful data.
• Risk Mitigation Strategies: Early identification of potential safety concerns can help modify the development plan and avoid costly setbacks later in the process.
• Comprehensive Data Documentation: Maintaining thorough records of study methodologies, results, and interpretations is vital for regulatory submissions.