What we can do
Drug Development Consulting
The identification and selection of a development candidate is a complex process, often based on specificity and efficacy in an in vitro or animal model. However, the estimation of oral absorption, first-pass effect, metabolic clearance and the presumed cascade of metabolization are also part of the selection parameters. As reliable data is often lacking, experience plays an important role.
The development of the dosage form that is suitable for the planned clinical application takes place in parallel with the preclinical phase. In addition to the physico-chemical and biopharmaceutical properties of the drug substance, the method of application and the intended dose of the drug substance must also be taken into account. Appropriate studies on formulation development, the manufacturing process and quality assurance and their timely commencement are of considerable importance for the start of clinical trials.
Once a candidate has been selected, an exciting interaction between preclinical safety testing and tolerability in humans begins. A lot of development time can be saved by smooth planning of toxicology and clinical pharmacology and by confident handling of CROs and ECs.
Project Development and Project Management Consulting
The development of a medicinal product is a complex process in which sub-processes of several functions must be coordinated with each other so that a consistent and time-saving (time to market) overall development can take place. The aim is to realize medicinal products and consumer health products quickly and in accordance with the relevant guidelines.
This includes the planning (network planning), monitoring and evaluation of experimental studies in the clinical, preclinical and pharmaceutical development areas (drug dosage form development, prodrug concepts, ICH-compliant quality studies).
Identification of qualified service providers, report preparation, investigator brochures and preparation of dossier parts for approval documents (EMA, FDA).
Consulting Economic Evaluation of Development Projects
The economic and financial evaluation of R&D projects from the early development phase is useful to determine whether a project development promises to be profitable and also to know the value of the project when negotiating with investors.
Parameters of the target market, development times, probabilities of realization are used to calculate the risk-adjusted net present value (rNPV) of the project. For critical paths during the development phase, a sensitivity analysis can be used to derive options for management action.