FDA and Regulatory Filing Strategy
Developing an effective filing strategy for a prescription drug or medical device requires a deep understanding of the regulatory landscape and FDA procedures. Avalere staff with real-world industry and government experience can help your team navigate this critical step in product development.Overview
A Complex Path
Navigating the intricate and ever-shifting Food & Drug Administration (FDA) regulatory landscape is a necessity for life sciences companies launching new products or indications. A well-defined filing strategy based on a holistic understanding of the regulatory landscape is crucial for manufacturers navigating the complex FDA approval process. There are several key decision points in this process: the initial Investigational New Drug Application in the pre-clinical phase, the Biologics License Application or New Drug Application in the clinical phase, and finally the FDA review. When skillfully navigated, these junctures are opportunities to develop data and value messages that can inform commercialization strategies and market success.
Trusted Partnership
We work closely with life sciences firms to develop comprehensive FDA engagement strategies that are tailored to an individual product’s therapeutic area, competitive landscape, and market access objectives. With experience in both industry and the FDA, our team has a proven track record of developing solutions to help our clients bring their products to market and satisfy regulatory requirements.
Avalere offers not only a comprehensive understanding of current FDA policies but also a finger on the pulse of scientific and industry advancements that may influence future guidance and agency decision making.
Defining Market Access and Commercialization
Market access and commercialization encompasses the successive steps required to develop and support a life sciences product launch. During the R&D phase, treatment gap identification and the competitive environment must be properly assessed; in pre-launch, channel strategies and pricing defined. Finally, ongoing stakeholder engagement and evidence generation to support global product expansion are critical in the post-launch phase.
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Featured FDA and Regulatory Filing Strategy Experts
Omar Hafez
Omar advises a range of clients on issues including supply chain, drug pricing, launch strategy, and oncology market analytics and planning.
Miron Dilmanian
Miron Dilmanian supports clients by providing a unique perspective at the intersection of science, policy, and communications.
Mina Allo
Mina Allo provides strategic consulting and pragmatic solutions to life science and managed care organizations around market access, health economics and outcomes research, real-world evidence, pharmaceutical benefit design, and population health strategies.