Product Development Consulting
Careful attention to detail, constant vigilance, and optimization of limited resources.
Regulatory and product development strategies and clinical development plans
Integration of preclinical and clinical strategies and operations
Execution of development strategies for successful global regulatory submissions
Ongoing regulatory and quality changes supporting lifecycle management
Premier Consulting: Specialized Support for Complex Development and Regulatory Programs
Premier Consulting is a strategic product development and global regulatory consulting brand dedicated to supporting the specialized needs of emerging biotech and specialty pharma companies. These small to midsize companies are the very heart of drug development. Like them, Premier Consulting is dedicated to the patient journey and are driven by the challenges of bringing new life-saving technologies to market.
Informed by its Built for Biotech™ core capabilities, Premier Consulting delivers end-to-end strategy, regulatory, nonclinical, CMC, quality, and commercial solutions that are best in class. With a customer-centric culture, Premier Consulting couples efficiency with quality while guiding sponsors every step of the way to commercialization. Premier Consulting tailors development plans to meet the most rigorous global regulatory requirements and deliver results for sponsors – and the patients they serve.
Learn more at Premier Consulting.
Drive regulatory and commercial success for your drug, device, or combination product through a comprehensive strategic approach and development plan.
Ensure flawless interactions with regulatory agencies—from initial strategy, to submissions and meetings—informed by frequent interactions and up-to-date information.
Clinical & PK
Move your product efficiently and successfully through the clinic using a customized clinical design solution with an eye towards differentiated product labeling.
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.
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.
Maximize the potential of your program throughout development and the commercial lifecycle with strategic insights that position your product for success.
Avoiding clinical holds
A clinical hold from the FDA can significantly prolong the time and increase the cost of drug development. Learn common reasons for clinical holds and useful tips for both avoiding and addressing them.
Optimizing the TPP
The path to approval becomes more efficient from both a time and resource perspective by beginning the development cycle with the end in mind. The first step along the way is the TPP.