Pharma Biotech Consultants
Clinical Development and Medical Affairs
Our extensive drug development expertise covers diversified therapeutic areas in a wide range of indications, spanning from phase I to phase IV, we:
Strengthen diversified therapeutic franchises across all life cycle phases and maximize the commercial value of in-market products through new indications and line-extensions.
Devise pharmaco-economic strategies (dossiers) to support Fair Market Value backing for pricing & reimbursement negotiations.
Design the appropriate PRO (Patient’s Research Outcome) tools, including appropriate quality of life scales in order to support pricing and reimbursement strategies.
Develop appropriate models with CHAD.
Develop and update analog research data to support value dossier.
Define the best strategy to analyze and report data; this includes sophisticated analyses and graphs that will help understand and interpret the data supporting an indication.
Conduct complex epidemiological data analyses.
Help guide product portfolio decisions: clinical and regulatory due diligence, market evaluation/ risk assessment of in-licensing opportunities.
Help conceive, develop and update Business Plans.
Extensive experience in interacting with major agencies across the world (FDA, Health Canada, EMA, Swiss Medic, PMDA, TGA, SFDA), we will help you:
Evaluate complex safety issues using a combination of traditional safety analyses and data mining associated with multidimensional space exploration: