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The Target Product Profile is the ‘blue-print’ of the future product and the guiding document for clinical development, the targeted patient population at launch, the assessment of the competitive strength vis-à-vis  pipeline products, and the sales forecast.

Target Product Profile– development, review, and market validation

TPPs reflect the properties of the future product and thereby define the scope of investment. They also reflect criteria for stop/go decisions for individual development activities. In conjunction with the development plan TPPs therefore illustrate a project’s value inflection points. We use TPPs as a common element of financial asset valuation. We also provide TPPs as a ‘stand-alone’ service for development candidates or as a tool to facilitate the prioritization of therapeutic indications.

In R&D management, the concept of the TPP is commonly used as a strategic document to align all development activities across functions. It is one of the most relevant tools used in project management.

TPPs reflect development goals. They are established for one indication, one formulation, and one target label.

The development of a product for several indications or in various formulations would require the respective number of TPPs. The TPP reflects both regulatory and market/market access requirements such that the probability of registration and commercial success is maximized.

We also provide TPPs requested by regulatory agencies to facilitate communication. Regulatory TPP templates do not only require the definition of development goals, but also a detailed description of the trial design and obtained development results.