Product Development & Regulatory Consulting

Offering decades of strategic development experience, global compliance, and therapeutic experience to ensure your promising therapy isn’t delayed by risk or limited resources.

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Achieving commercial success

Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success.

PREMIER PERSPECTIVE

Product development checklist

A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success, especially for small biotech and specialty pharma companies working with limited time and resources.

Taking your product to the next level

Our consultants work with you to design and implement comprehensive plans to enable successful product development from early discovery through IND and post-approval lifecycle management, supporting the regulatory pathway and tactical implementation.

Premier Thought Leaders

Sameena Sharif

Sameena Sharif

President, RPI, A Division of Premier Research
Shari Medendorp

Shari Medendorp

SVP, Biometrics
Kristi Miller

Kristi Miller

Vice President, Regulatory Affairs Strategy, RPI, a Division of Premier Research
Nach Davé

Nach Davé

Vice President, Development Strategy

Related Capabilities

Adding value at every step in the process, we provide expertise in global regulatory consulting, clinical R&D, and technology tools to ensure your trial’s data integrity, process efficiency, and timely analytics and reporting.

Global Regulatory Consulting

Global Regulatory Consulting

Clinical Research & Development

Clinical Research & Development

Premier Ecosystem

Premier Ecosystem

Therapeutic Focus

Therapeutic Focus

Therapeutic Focus

There’s no substitute for experience. And we have a lot of it. See what we’ve been busy doing for the past five years.

Check out our resource center

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

CASE STUDIES

CASE STUDIES

WHITE PAPERS

WHITE PAPERS

WEBINARS

WEBINARS

VIDEOS

VIDEOS

PODCASTS

PODCASTS

Connect with us

Ready to get started? So are we. Drop us a line to learn more about how we can help.