Product Development Consulting

Careful attention to detail, constant vigilance, and optimization of limited resources.

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Preclinical

Preclinical

Regulatory and product development strategies and clinical development plans

Clinical

Clinical

Integration of preclinical and clinical strategies and operations

Execution of development strategies for successful global regulatory submissions

Post-Approval

Post-Approval

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.

RPI & Camargo: Specialized support for complex development programs 

Camargo Pharmaceutical Services, A Division of Premier Research, is a recent acquisition that will enhance and strengthen our current Regulatory Professionals consulting group for product planning, development, and differentiation services. Camargo is a leading global strategy, regulatory, and commercial partner for emerging biopharma companies with expertise in areas such as oncology, pediatrics, rare disease, and 505(b)(2) product development. Learn more here.

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

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.

Regulatory

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.

Quality

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.

PREMIER PERSPECTIVE

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.

PREMIER PERSPECTIVE

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.

Check out our resource center

Our experts have developed an extensive library of white papers, case studies, blogposts, and other informative resources.

PREMIER INSIGHTS

PREMIER INSIGHTS

WHITE PAPERS

WHITE PAPERS

WEBINARS

WEBINARS

VIDEOS

VIDEOS

PODCASTS

PODCASTS

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