Bringing a new therapy to market is complex. Missed milestones, regulatory missteps, and unclear positioning can cost both time and opportunity. Our integrated approach to drug and device development strategy provides the clarity and foresight you need to move forward with confidence.

From regulatory planning to clinical strategy to market access alignment, Premier’s specialized development consultants and clinical experts will help you navigate every step of the development journey—mitigating risk, optimizing timelines, and maximizing your asset’s potential.

With our support, you can:

• Accelerate timelines from preclinical to clinical development
• Mitigate regulatory risk with proactive planning
• Align clinical development, regulatory, and commercial objectives
• Maximize asset value through strategic decision-making

Our Strategic Services: Comprehensive Support From Pre-IND through Commercialization

Product Concept Evaluation and Target Product Profile

You need a clear, unified vision of your product’s potential to effectively plan and address evolving development demands. Premier experts assess development risks and opportunities against the latest regulatory requirements and competitive landscape to clearly identify the potential of your asset.

Leveraging a fully integrated project team, we can deliver a complete product evaluation and target product profile that unifies clinical, regulatory, and commercial priorities. This evaluation becomes an anchor for alignment throughout the life of your program.

Integrated Regulatory Strategy

Once your product has been thoroughly evaluated and your development objectives are clearly defined, Premier’s seasoned regulatory experts help to lead integrated planning. With a regulatory and goal-oriented mindset, we identify ways to optimize your program to address regulatory requirements and position your asset for long-term success.

Premier’s regulatory experts will pursue an integrated approach, identifying the right clinical and commercial expertise within our team to craft a development plan based on your program’s unique characteristics, accounting for regulatory precedent, the competitive landscape, resource demands, and time-to-market considerations.

Clinical Development Plan

Led by our regulatory experts and leveraging a cross-functional team, we deliver a clinical development plan that aligns clinical milestones with regulatory goals and commercial objectives to reduce risk and enhance success. Our expert guidance includes time- and cost-to-market analysis, risk analysis and mitigation, regulatory engagement, health authority feedback, necessary trials, and critical milestones.

Your clinical plan should do more than advance your trial—it should drive your entire development program. We’ll deliver:

• Phase-appropriate trial strategies
• Key considerations for CMC, nonclinical and toxicology planning
• Risk identification and mitigation plans
• Integrated regulatory input

Customized Regulatory & Development Consulting 

From engaging with health authorities to determining necessary nonclinical and preclinical steps to developing CMC recommendations and beyond, we offer tailored solutions to meet the specific needs of your program. We have a deep bench of experts knowledgeable across a wide range of therapeutic areas, asset types, countries, and regulatory pathways and frameworks—ensuring strategic insight at every step.

Why Choose Premier?

• Decades of experience guiding drug development programs
• Global regulatory expertise in key regulatory pathways supporting both drug and device development
• Deep therapeutic area insights
• Market access strategy embedded from the start
• Flexible, tailored support for emerging and established sponsors alike

A Unified Team. A Smarter, Faster Path to Approval.

With decades of experience across regulatory, clinical, and commercial strategy, our team brings deep cross-functional insight into every engagement. Contact Premier today to build a roadmap that leads to success.​