Non-clinical and toxicology development services
Your Path to Preclinical Excellence
Navigating to clinical phase and market success through expert preclinical strategy and development
Early-stage drug safety assessment based on pharmacology and toxicology studies is vital when entering clinical trials and achieving market authorization. Our expert team designs a robust preclinical strategy and development plan, utilizing available data to minimize preclinical study requirements. We identify the ideal preclinical laboratory, establish GLP-compliant study designs, offer dedicated project management, and update your Investigator’s brochure and IMPD with available preclinical data. Our preclinical expertise will guide you to make informed decisions on clinical dose selection. We excel in thorough non-clinical document evaluation, specializing in environmental risk assessments, impurity qualification reports, and preparing complex analyses of submitted preclinical data. This ensures a smooth transition from preclinical to clinical development of your pharmaceutical product.
Ensuring Success in the Path of Your Pharmaceutical Product
- Our team comprises seasoned professionals, including doctors, toxicologists, chemists, and pharmacists, who offer deep understanding and scientific knowledge to every project.
- We provide various geographical locations across the globe, covering multiple time zones and supporting clients for an extended period of time.
- Our portfolio of successful projects reflects our ability to work on all types of products, from complex generics and biosimilars, to new chemical entities and biologics.
