Featured Case Studies

Insight-driven and inventively bold, we excel in building strategies and developing highly customized programs. Our experience—from custom-designed clinical research studies to FDA registration and approval to commercialization—allows us to establish the best path to optimal outcomes.

De-risking the NDA Process: Analysis, Strategy, and Cross-Disciplinary Expertise.

De-risking the NDA Process: Analysis, Strategy, and Cross-Disciplinary Expertise. The Sponsor had developed a game-changing...

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Optimizing the Market Value of an Asset with Multiple Potential Indications

Research and development (R&D) investment decisions may be the largest risk taken by drug developers....

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Expediting Regulatory Decisions: Coordinating Dual Active Substance Master File (ASMF) Submissions

The Marketing Authorization (MA) holder for a treatment for onychomycosis, having previously secured regulatory approval...

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Using RWD and RWE to Support an Ultra-Rare Orphan Program

Clinical trials for ultra-rare diseases can be particularly challenging to mount. Typically, the patient population...

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Patient-Centric Approach and FDA Expertise Lead to Orphan Approval

By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.

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Aligning for 505(b)(2) Success: Oncology Combination Product First-in-class Treatment Success

Throughout the lifecycle of a drug development program, sponsors are confronted with a range of…

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Multidisciplinary Team Advances Immuno-Oncology Development

Date: July 24, 2020 Author: Ruth Stevens, PhD, MBA Project Lead: Stacey Ayres, PhD In...

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Combination Product Expertise and Target Market Knowledge Secure Fast-Track Review

By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.

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Leveraging 505(b)(2): Real-World Evidence Rescues Program

When a biotech company could not afford the time and expense to conduct intended studies, we stepped in and quickly and creatively turned things around with the FDA.

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Rapid Nonclinical Planning and Coordination Keep Post-Marketing Requirements on Track

Premier Consulting selected CROs to run the multi-species genotoxicity program within the FDA’s agreed-upon timelines.

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Strategic Submission Preparation Redefines Product Value

With strategic submission support, a biotech company gained approval for an improved delivery technology of an already-approved drug, setting the potential to become a new “gold standard” treatment in oncology.

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