A systematic process to identify and evaluate the discrepancies between the current state of product development and the regulatory requirements, highlighting areas that need improvement or further research.
Determine a project’s current Technology Readiness Level (TRL), providing a clear understanding of its development stage and aligning the product’s development stage with the relevant regulatory landscape, ensuring compliance with all necessary regulations.
Designing strategies that guide drug development projects from the initial
stages to registration, ensuring alignment with regulatory requirements for approval
and market entry.
Train and empower both new entrants and seasoned professionals in the pharmaceutical sector. We specialize in equipping individuals with the knowledge and skills necessary to navigate the complex landscape of regulatory strategy for drug development.
Support both investors and startups in the pharma sector. We specialize in developing investment strategies that leverage the regulatory maturity of drug development projects, providing valuable insights and guidance to startups aiming to attract investment and scale their operations.
Strategic and end-to-end project management, ensuring compliance with
regulatory, ethical, technical and market requirements, coordinating partners and
providers involved in all stages of development – from research to market.