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Built for BiotechSM

We are scientists, researchers, strategists, and innovators on a mission to help biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments for patients.| Premier Consulting provides strategic product development and global regulatory consulting services with unparalleled nonclinical, CMC, quality, clinical, and commercial expertise. We offer end-to-end strategic insights to help biotech companies advance their programs through every development milestone, from the earliest stages through commercialization.| Providing a full range of strategic support, from product concept to regulatory interactions to submissions, we help sponsors approach their programs with confidence – minimizing risk and enabling decisions from a position of knowledge and strength.

About Us

Strategic Product Development Solutions

Across the development lifecycle, our integrated solutions and cross-functional team provide customized support for your program—from the earliest stages of strategy and planning through FDA approval to commercialization.

Strategy

Drive regulatory and commercial success for your drug, device, or combination product through a comprehensive strategic approach and development plan.

Strategy

Regulatory

Ensure flawless interactions with regulatory agencies—from initial strategy, to submissions and meetings—informed by frequent interactions and up-to-date information.

Regulatory

Clinical & PK

Move your product efficiently and successfully through the clinic using a customized clinical design solution with an eye towards differentiated product labeling.

Clinical & PK

CMC Services

Avoid unnecessary delays and costs by integrating CMC components early in the development program, including strategic insights and management on vendors, processes, and quality controls.

CMC Services

Nonclinical

Reduce short- and long-term costs through a robust nonclinical program with support in methodology and strategy, study design, development, and accountability for program execution.

Nonclinical

Commercial

Maximize the potential of your program throughout development and the commercial lifecycle with strategic insights that position your product for success.

Commercial

Experts in the Path to Approval

We have experience in accelerated approval pathways, rare and specialty patient populations, and innovative science for both novel and 505(b)(2) products, including orphan drugs, oncology, neurology, pediatrics, combination products, and digital therapeutics.

Novel Therapeutics Expertise 505(b)(2) Expertise

Latest Insights

Blog & Resources