Development Consulting

Providing strategic and regulatory solutions for all phases of drug development, from clinical through post-marketing support in the U.S., Europe, and Asia-Pacific.

 

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Leveraging decades of strategic development experience and professionals who are positioned to support you with a customized, Built for Biotech approach:

  • Product development strategy and plans
  • Target Product Profile (TPP)
  • Clinical Development Plan
  • Regulatory development strategy
  • Clinical pharmacology
  • Non-clinical strategies
  • Timeline generation, critical risk identification, and contingency planning
  • Communication and publication strategies
  • Resource planning

WEBINAR

FDA’s updated guidance

In 2019, the U.S. Food and Drug Administration updated its draft guidelines for drug discovery in rare diseases. The changes can help sponsors perform more efficient development programs and gain new insights on the development process.

PREMIER PERSPECTIVE

Preparing your IND application

There are many pitfalls that come with preparing an Investigational New Drug application for FDA submission, but with the right plan – and the right partner – there are also plenty of ways to avoid them.

Related services

Development consulting is part of a wide range of service offerings that include regulatory consulting, global compliance, and study start-up. Follow the links below to learn more about how clients gain from our specialized expertise.

Regulatory Consulting

Global Compliance

Study Start‑Up

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

Connect with us

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