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
Regulatory Professionals, A Division of Premier Research, can help you design and implement a comprehensive plan to enable product development from early discovery through IND and post-approval lifecycle management.
The RPI product development framework is built on the foundation of our strategic and tactical regulatory expertise. With access to a range of clinical research experts including therapeutic specialists, biostatisticians, and clinical operations, RPI consulting can help design a product development plan that reduces risk and maximizes commercial success.
A clearly defined regulatory strategy sets the stage for a robust product development program, clarifying critical requirements for approval. Learn how RPI can help below.
Nonclinical testing is critical for assessing the safety and pharmacokinetic characteristics of a product. We offer expertise in the design, management, and reporting of nonclinical programs.
We offer full-service regulatory expertise across all phases of product development, including gap analysis, development strategy, fast-track applications and priority review, and safety.
Chemistry, Manufacturing, and Controls (CMC)
We support your team in ensuring that your pharmaceutical products are manufactured for nonclinical and clinical testing through commercialization and post-approval lifecycle management.
With our deep experience in all areas of GxPs, we help clients with developing quality infrastructure, providing quality oversight, ensuring compliance, and even preparing for audits.
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.