Strategic Clinical Pharmacology Solutions to Move Your Program Forward Efficiently

Understanding how your drug behaves in the body is essential for successful development. In fact, 70–80% of clinical failures are linked to insufficient efficacy or unacceptable toxicity—issues that often stem from suboptimal dosing strategies.

With expert clinical pharmacology support, you can proactively address these risks. Our strategic, data-driven approach enables you to:

• Optimize dosing
• Improve safety profiles
• Increase trial success rates
• Accelerate development timelines
• Reduce costly delays

Driving Smarter, Faster Drug Development

Our clinical pharmacology services are designed to generate the critical data you need—early and throughout development—to make informed decisions and meet regulatory expectations with confidence.

We specialize in evaluating:

• Pharmacokinetics (PK)
• Pharmacodynamics (PD)
• Drug-drug interactions (DDIs)
• Special populations (pediatrics, renal and hepatic impairment)
• Intrinsic factors such as age, gender, weight, and ethnicity

Expert-Led, End-to-End Support

Our experts deliver strategic insights that drive smarter, faster drug development and provide strategic insights and scientific rigor across every phase of development. From designing targeted studies for ADME, mass balance, and special populations (renal, hepatic, pediatric, geriatric, lactation) to reviewing protocols and synopses, we help ensure your clinical program is built on a solid scientific foundation.

• Design and review of targeted studies for ADME, mass balance, and special populations (renal, hepatic, pediatric, geriatric, lactation)
• Protocol and synopsis development
• PK/PD analysis using noncompartmental (NCA) methods
• Interpretation and reporting of results throughout development to inform decision making, maximize data value and reduce uncertainty

We provide end-to-end PK support, including robust PK/PD analysis using noncompartmental (NCA) methods—empowering you to make confident biopharmaceutical decisions at every stage.

505(b)(2) and Complex Program Expertise

We are highly specialized in supporting 505(b)(2) drug development programs and FDA submissions. Leveraging this deep expertise, we design effective strategies to streamline regulatory approval and reduce development timelines.

• Bridging strategies
• Cross-study evaluations
• Selection of listed drugs (LDs)
• Biowaiver justifications
• Combination product development

Our targeted approach streamlines your regulatory pathway and shortens time to market.

Study Design and Development Planning

Our experts will develop customized clinical pharmacology and clinical plans for your products. We help you design and execute the right studies at the right time, so you can confidently navigate clinical development, mitigating risks and accelerating regulatory success.

We specialize in the planning and design of innovative clinical studies critical to your program’s success and keep you moving from early development to approval with speed and confidence.

• Specialized pediatric drug development plans
• SAD/MAD and FIH trials, including dose selection strategy
• Phase 2 and Phase 3 studies
• QTc and impairment studies
• Bioanalytical method validation support
• BA/BE assessments
• Food effect studies

Regulatory Strategy and Reporting

Our expertise extends beyond data analysis to comprehensive regulatory support—ensuring your clinical pharmacology data is clearly interpreted, rigorously reviewed, and expertly communicated.

• PK/PD Data Interpretation & Reporting: We deliver clear, actionable insights from your clinical PK and PD results, backed by thorough data quality reviews and troubleshooting to ensure accuracy and reliability.
• Scientific & Medical Writing: Our team prepares high-quality PK/PD reports, clinical study reports (CSRs), and briefing documents that effectively convey your findings to regulators. We also develop critical clinical modules for IND and NDA submissions (Modules 2.5, 2.7.1–2.7.6).
• Regulatory Expertise: From early planning through submission, we guide and author key regulatory documents for Type A, B, C, and D meetings. Our support spans pre-IND, IND, and NDA filings, helping you navigate complex regulatory pathways and accelerate approval timelines.

Why Partner With Us?

Premier will tailor our services to meet your specific development needs, providing comprehensive and actionable plans with oversight from functional experts.

• Depth of Experience – A seasoned team with extensive experience across therapeutic areas
• Integrated Approach – From early development through approval, we align strategy, science, and regulatory insight
• Proven Results – Our work has contributed to numerous successful submissions and regulatory approvals

Contact Premier today to optimize your clinical pharmacology program—so you can move forward with clarity and confidence.