PRECLINICAL DEVELOPMENT
Early clinical development requires a strategic, technical and regulatory
expertise. Thelonius Mind provides efficacy and experience
to assistance you plan and advance your program.
We guide your drug discovery and development process from concept to clinic. Our preclinical development services are designed to ensure your program is built with critical evaluations and strategic guidance.
We guide your drug discovery and development process from concept to clinic. Our preclinical development services are designed to ensure your program is built with critical evaluations and strategic guidance.
GUIDANCE ON SELECTION
OF PRECLINICAL MODELS
Our team provides expert advice on the most appropriate models for your research, ensuring that your studies are both relevant and reliable.
ANALYSIS OF MoA TO
SELECT TARGET INDICATIONS
We offer in-depth MoA analysis to help you identify the most promising therapeutic areas, increasing the likelihood of successful outcomes in clinical trials.
CRITICAL EVALUATION
Our expert team conducts comprehensive reviews of existing studies and documentation, identifying gaps and opportunities to optimize your research.
Advice on tailoring regulatory preclinical study package
Our experts provide tailored advice on designing and conducting preclinical studies, ensuring they meet regulatory requirements and provide the necessary safety data to support early clinical development.
PRECLINICAL DEVELOPMENT
REQUIREMENTS
PREPARATION
TOXICITY STUDY PACKAGE
DESIGN
REGULATORY
COMPLIANCE
Ensure compliance with regulatory
requirements and guidelines set by agencies like the FDA or EMA. Clients need preclinical data that meet regulatory standards to support their Investigational New Drug (IND) application or equivalent.
RISK MITIGATION
Identify and mitigate potential risks associated with the product’s development. This includes addressing safety concerns, support for clinical development strategy, optimizing manufacturing processes, and preparing for potential regulatory challenges.
TIMELINE AND BUDGET
MANAGEMENT
Manage timelines and budgets effectively to ensure efficient progression through preclinical development stages. Support clients to minimize delays and costs while maintaining high-quality data generation.
