Target Product Profile

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All the best plans start with the end in mind. In drug development, that’s the target product profile–a tool for regulatory communication–and we’ll help you define this early on, avoiding issues later.

 

Developing a target product profile with clear commercial goals in mind helps balance the ideal product description, a minimal accepted product description, and something in between–closely resembling your eventual product label. We’ll help you outline the desired ‘profile’ or characteristics of your product.

 

Efficiency through clarity

 

During strategy workshops we’ll work with you to develop a clear vision that supports the design, conduct, and analyses of clinical trials, towards a smoother path for overall development.

We’ll help you steer internal processes and direct resources, saving money and time. The process will be an invaluable step in providing guidance for investors and upper management, too, as well as regulators.

We understand that your target product profile, by necessity, will be a highly dynamic document which evolves over time, so we’ll allow for that from day one.

 

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Insights Hub

Sharing insights, questioning norms, asking the right questions - we'll never lose sight of what you're striving for. Our insight and expertise will help you bring the most innovative therapies within reach of patients around the world.
29.11.21
Biopharma Excellence

Roadmap to commercialization success: Build agility into drug development plans

By Dr. Diane Seimetz

We know the lifechanging impact that gene, cell and tissue-based therapies..

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If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.

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