Strategic Solutions to Optimize Development at Every Stage

We know how important it is for you to reach critical development milestones on time and within budget. With integrated nonclinical and toxicology strategies, Premier can help you get to the clinic faster, adding efficiency to your drug development program from day one through to regulatory approval.

Our team brings diverse scientific and product development expertise in areas including ADME/PK, bioanalysis, CMC, pharmacology, toxicology, and early clinical development. We collaborate with Premier’s development strategists to streamline and advance drug programs, while leveraging Premier quality management capabilities to stay at the forefront of quality and compliance standards.

Our Experience:

Tailored Nonclinical Solutions to Meet Your Needs

Working as an extension of your team, we provide nonclinical and toxicology guidance to streamline development. Each Sponsor and project is unique, so we tailor nonclinical and toxicology support, data interpretation, study design, and regulatory strategy to optimize development plans. Using our extensive experience working with all major divisions of the FDA, we understand and incorporate the specific nonclinical requirements needed for various therapeutic areas and modalities across all our strategic solutions.

Early Research and Development

Targeted efficacy and safety screening supports early-stage decision-making, helping advance the most promising compounds.

• Compound screening and selection for efficacy and safety
• Proof-of-concept study design
• Safety screening approaches (in silico, in vitro, in vivo, etc.)
• Assessing data and recommending next steps to ensure smooth progression to more comprehensive studies

Strategic Assessments

Leveraging years of experience, we design efficient, data-driven nonclinical development plans to reduce cost and accelerate timelines.

• Nonclinical development options, including IND-enabling nonclinical/toxicology studies
• Developing the nonclinical plan and supporting rational
• Reducing the size of repurposed drug (e.g., 505(b)(2) NDA) nonclinical programs by leveraging available nonclinical data (e.g., approved drugs and literature)

Pre-IND Meetings

We’ll help you build a strong regulatory foundation with pre-IND strategies and FDA-ready study designs to improve the odds of program success from day one.

• Overall strategy and key questions to ask the FDA at pre-investigational new drug application (pre-IND) meetings
• Design of IND-enabling nonclinical/toxicology packages and designing/writing pivotal study synopses to ensure FDA agreement
• Human Equivalent Dose (HED) and First-In-Human starting dose setting

Nonclinical Study Design and Execution

Our experts manage all aspects of study design and execution to ensure regulatory compliance, quality, and alignment with development goals.

• Nonclinical study design, contracting, monitoring, and reporting (GLP and non-GLP) to maximize scientific quality and regulatory acceptance
• Ability to ensure nonclinical studies meet regulatory requirements (of the FDA, the EMA, the OECD, GLP compliance, etc.) and support clinical development and marketing approval
• Overall development cost reduction and timeline acceleration
• Ability to act as an extension of your team
• Ongoing nonclinical/toxicology study troubleshooting and input on GLP compliance issues

Regulatory Submissions

To support successful regulatory outcomes, our team prepares and reviews high-quality nonclinical submission content.

• Write and review nonclinical eCTD sections
• First-in-human starting dose (IND and CTA) and overall benefit:risk assessment (NDA and BLA)
• Excipient and impurity/degradant qualification, including in silico and QSAR analyses
• Biocompatibility assessments for devices and combination products

Specialized Nonclinical and Toxicology Study Designs and Programs

Specialized expertise allows us to design studies to meet the unique needs of complex and emerging therapies.

• Juvenile toxicity
• Combination toxicity (fixed dose combinations products, drug-device, biologic-device)
• Cell therapy studies and programs
• Gene therapy studies and programs
• Oncology studies and programs
• Biologic studies and programs
• Repurposed drug (e.g., 505(b)(2)) nonclinical studies and programs

Looking to Optimize Your Nonclinical and Toxicology Strategy?

Contact Premier today to discuss the best path forward.