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.
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
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.
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.