Nonclinical Support for FDA Regulatory Documents & Submissions
Pharmaceutical and biotechnology companies often face challenges when preparing to submit drug applications for regulatory approval. Nonclinical development for regulatory documents and submissions requires extensive knowledge and expertise to efficiently bring medications to the market. Exponent scientists within the Center for Toxicology and Mechanistic Biology provide the highest quality technical, regulatory, and safety assessment services to assist our clients with issues related to pharmaceutical and biotechnology products, with a particular focus on nonclinical development and regulatory support.
About Nonclinical Safety Assessments
Nonclinical safety assessment begins with careful study design, involves the management of laboratory testing, and requires careful analysis of toxicity, safety pharmacology, and toxicokinetic data. Additionally, studies done to support an investigational or new drug application must comply with regulatory guidelines to demonstrate both the safety and efficacy of the drug. Due to the time- and cost-intensive nature of developing these types of data, it is prudent to maximize the value of the research and development dollars spent by strategizing ways to streamline studies, reduce expenses, and ensure that useful data are generated the first time around without the need for additional studies. Further, when a questionable finding arises in a nonclinical study, additional research may be required to resolve the clinical relevance of the finding.
How Exponent Can Help
Our team has the technical expertise necessary to assist our clients in all stages of nonclinical development and the regulatory approval process, including:
- Development of customized testing strategies to reduce costs and maximize the likelihood of moving drug candidates into the clinic and beyond
- Identification of appropriate animal models for nonclinical safety assessment
- Expertise in small and large molecules, and other novel therapeutics
- Identification of appropriate contract research organizations (CROs), study design and management, and selection of appropriate doses for safety testing and first in human
- Nonclinical issues research and resolution
- Data analysis and regulatory document preparation
- Regulatory support for both investigational new drug (IND) applications and new drug applications (NDAs)
- Representation during meetings with FDA and other regulatory bodies
- Environmental impact assessments.
John M. DeSesso, Ph.D., DABFM, DABFE, FACFEI, DABCHS, Fellow ATSToxicology & Mechanistic BiologyCenter Director, Office Director & Principal ScientistAlexandria