Nonclinical studies define the relevant efficacy and/or safety characteristics of drugs, biologics, and medical devices. They begin well before a Sponsor’s first interaction with the Food and Drug Administration (FDA) and continue throughout product development. Having a sound nonclinical development program can help assure that time and resources are not spent on studies that fail to address the issues of concern to regulatory authorities, and thus may need to be repeated.
Our nonclinical consultants can help maximize a Sponsor’s potential for success by designing pharmacology, pharmacokinetics, and toxicology programs that are appropriate to support the intended indication, route of administration, and duration of treatment for your product. In addition, we can provide the following operational toxicology support:
- Nonclinical Study Design, Placement, and Monitoring
- Discovery Stage Assistance
- Nonclinical Results Analysis and Design of Follow-On Work
Our experts have a deep understanding of regulatory requirements for nonclinical and clinical development programs, ensuring that a Sponsor’s studies are commensurate with the development status of a product and that these endeavors address regulatory expectations.
Nonclinical Data Review and Analysis
Sometimes new nonclinical studies are not necessary. Our consultants will work with you to determine when it may be adequate to rely on other sources of publicly available information to support the safety of your product. For example, safety data on already approved products under the regulatory purview of the FDA or other agencies (ie, the US Environmental Protection Agency [EPA]) can be used to substantiate the safety of individual active and inactive ingredients, impurities, and leachables that may be present in a Sponsor’s product.
Our experts have diverse backgrounds and significant experience with a range of FDA-regulated therapeutic products (drug, biologics, and medical devices), foods (conventional food ingredients and dietary supplements), and cosmetics, as well as potential toxicants regulated by the EPA that allow us to identify novel data sources and approaches to support product safety.
Once a Sponsor is ready to approach the FDA, our consultants can assist in preparing a summary of the Sponsor’s data. In this summary, we will integrate available data to present a cohesive story that is appropriate for the current stage of product development, while balancing the significance of the scientific findings with the proposed indication and patient population.
In addition to preparing classic nonclinical sections of regulatory submissions, our experts are adept at integrating original and published nonclinical and clinical data to support both labeling (eg, in Pregnancy and Lactation Labeling Rule [PLLR] white papers) and the safety of the intentional (active and inactive ingredients) and unintentional (starting materials, intermediates, degradants, residual solvents, elemental impurities, and leachables) substances that may be present in a Sponsor’s product.
ProPharma Group: Nonclinical Development Experts
Nonclinical components of drug development set the stage for everything that follows. Navigating milestones successfully is critical for your drug development program to move forward. We can work with you to ensure that your studies are conducted in compliance with all of the FDA’s regulations, your data is sufficient and is presented appropriately, and help you compile and submit a successful nonclinical summary to the Agency.