Strategic Product Development

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

prcom_Asset 1ARROW

PREMIER PERSPECTIVE

Opportunities in APAC

Small and mid-size biopharma companies in the U.S. and Europe are under pressure to find more efficient ways to commercialize their products. As a result, sponsors have begun to shift their focus to the Asia-Pacific region for their studies.

PREMIER PERSPECTIVE

IND applications: 4 common mistakes

Before a Phase 1 trial begins, an investigational new drug application must be approved by the FDA. This critical step grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval.

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

Colin Hayward

Colin Hayward

Chief Medical Officer
Kristi Miller

Kristi Miller

Head of Global Regulatory Affairs Strategy, RPI, a Division of Premier Research
Sameena Sharif

Sameena Sharif

Senior Vice President, Product Development, 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 clinical R&D, medical device and diagnostics, and technology tools to ensure your trial’s data integrity, process efficiency, and timely analytics and reporting.

Clinical Research and Development

Clinical Research and Development

Medical Device & Diagnostics

Medical Device & Diagnostics

ePremier Technology Platform

ePremier Technology Platform

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.