Development & Strategy Regulatory Strategy & Consulting

In the highly regulated environment of drug development, it is important to evaluate regulatory pathways and obtain buy-in from governing regulatory bodies as early as possible. This ensures speed to market and minimizes the potential for delays. CTI has a team of dedicated professionals with more than 30 years in regulatory, clinical, and management experience, including former US Food and Drug Administration (FDA) committee members and individuals with European Medicines Association (EMA) expertise. This background in regulatory strategy and consulting makes us a strong partner for any organization with needs in this area.

Lynn Fallon, BSN
President
Since she co-founded CTI, Lynn has been instrumental in guiding the regulatory process for several pharmaceutical and biotechnology companies, and she continues to draw on her experience to effectively guide our sponsors through complex regulatory environments.

We have negotiated regulatory pathways on behalf of our sponsors with several regulatory bodies around the world, including experience with:

• Orphan Designations
• Breakthrough Designations
• Fast Track Designations
• Adaptive Design Programs
• Direct-to-patient Programs
• Hybrid Programs
• PRIME Programs