The end-to-end journey for innovation to advance and generate impact.
Identify and assess gaps between a product’s current development status and regulatory requirements, providing a detailed roadmap for enhancements or additional research needed for compliance.
Develop a comprehensive strategy for guiding drug development from early-stage research through regulatory approval processes, ensuring readiness for the clinical stage in line with industry standards.
Create a strategic approach for clinical-stage development and regulatory alignment, guiding projects through clinical trials to product registration and market entry.
Support documentation, review, and submission of the required regulatory dossiers, ensuring all requirements for trial initiation.
Provide expertise in compiling, reviewing, and submitting the necessary documentation for successful product registration, facilitating market readiness.
Provide strategic and end-to-end project management, identifying and coordinating the right partners for each phase of the product development and ensuring compliance with regulatory, ethical, technical, and market requirements, from initial research to market launch.
Evaluate and prioritize internal projects (from companies and investors), focusing on innovation potential, technological maturity, regulatory framework, quality assurance, and scalability to accelerate strategic project development.
Active market search for high-value projects (for companies and investors), tailored to therapeutic interests and innovation priorities, ensuring alignment with regulatory, quality, and scalability standards.
Foster partnerships and collaborate with public and private entities to build a robust health ecosystem, advancing innovation and scientific development across the region.
Support connections between innovative projects and investors, identifying the best opportunities by assessing technical and technological maturity factors for optimal investment alignment.
Connect Brazilian companies with international entities, establishing strategic partnerships to facilitate market entry for new products in the country.
Empower professionals in regulatory strategy, providing in-depth training to navigate drug development regulations effectively.