Establish the Target Product Profile (TPP)

Service description

The Target Product Profile is a central dynamic document of the preclinical research to define the and manage the therapeutic goals and properties of the new drug. It is the first part of the Quality by Design concept. Implemented now by the major drug approval agencies, e.g. EMA, FDA, NMPA and part of the ICH guideline Q8 (R2) on pharmaceutical development guidelines. GPRS supports the customers to establish the document by identification of the profitable disease area, patient population, route of administration, delivery system, dosage form, required pharmacokinetic properties needed to generate the therapeutic effect, safety parameters, potential side effects and anti target profile, and quality of the active pharmaceutical ingredients (API). We develop this together with clinical experts in our network together with the customers.

Sector

Pharmaceuticals

Health and medical care

Biotechnology

Technology Readiness Level

TRL 1 – Basic principles observed

TRL 2 – Technology concept formulated

TRL 3 – Experimental proof of concept

TRL 4 – Technology validated in lab

TRL 5 – Technology validated in relevant environment

TRL 6 – Technology demonstrated in relevant environment

TRL 7 – System prototype demonstration in operational environment

TRL 8 – System complete and qualified

TRL 9 – Actual system proven in operational environment

Financial requirements

300 €/hours for a short engagement of up to 2 days. For longer contracts reductions down to 150 €/hours are possible. So, for EIC Awardees we offer a 25 % (<2 month) to 50 % (>2 month) reduction.

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