Risk Sharing and Partnering
Through our Risk Sharing and Partnering program, TFS offers a good solution to small- and midsized companies that may lack the experience or financial capacity to launch a compound throughout the different stages of the drug development chain. In such scenarios, payment is structured with a very limited upfront investment combined with a more substantial backload payment plan based on the success of the trial and the agreed exit for the compound. The Business Review Committee (BRC) at TFS evaluates and decides what projects qualify and will be accepted based on certain criteria.
Risk Sharing and Partnering program information
Click here to request more information about our Risk Sharing and Partnering program (Word-document, 70KB).
Pre-Clinical Development
This includes a wide range of studies such as vivo pilot experiments, proof-of-concept, pharmacokinetics, safety pharmacology, toxicity tests, immunisations and specific disease models. The test facilities and services are in full compliance with Good Laboratory Practice (GLP). Consultation services regarding pre-clinical project strategies are also provided.
Clinical Trials in phase I and II (human)
Clinical trials on humans are conducted from the early explorative studies, first-in-man dose, to the evaluation of the product's optimal dose-finding, efficacy and safety. The clinical trial services cover the early drug development in the clinical program from Phase I to Phase II trials. Clinical trials are performed in strict accordance with Good Clinical Practice (GCP) and all applicable laws and regulations.
Regulatory Affairs
Regulatory Affairs guides the direction of a project through all stages of development in order to secure a successful approval. It also monitors the approved drug throughout its life cycle thereby securing its presence on the market. The services include regulatory strategic advice, contact/negotiations with competent authorities, documentation throughout product development and fulfilling all the current authority requirements.
