We become part of your team and help you to firmly connect the science and strengths of the new drug to the patients and improve the value of your asset(s).
We help Best-In- Class/Innovative Companies succeed in product development and gain US/China regulatory approvals by providing additional expert level bandwidth and risk-managed commercial development strategy.
We add value and provide experienced subject matter know-how.
Product specific formulation and implementation of risk-managed, cost-effective commercial development strategies that achieve key product differentiation and POC/value inflection by addressing and mitigating risks and competitions.
We help position the product for the future by taking the rapidly evolving current SOC and regulatory requirements into account.
Extensive scientific, medical, regulatory and commercial development expertise in many therapeutic areas.
We help sponsors meet the global standards: FDA, NMPA, EMA, PMDA regulatory requirements and ICH (GxP) standards.
We help ensure FDA/EMA/NMPA/ROW regulatory compliance and interactions for PIND/IND, EOP2, NDA/BLA submissions.
Identify best pathways navigating the current SOC to create a new SOC with your product.
We provide critical talent capabilities for sponsors: medical, regulatory, ICH GCP, and best practices.
Experienced talent and executive leadership/management for US/ROW and China commercial oncology drug development.
We offer ICH GCP compliance, quality and efficient operability, and best practices management and operations.
Due Diligence and others
Investor and Corporate Support which includes Due Diligence, Navigation and Risk Management.
We provide deep market and product medical, pharmacology, safety, efficacy competitive analysis, and risk adjusted DCF/NPV assessment adjudication.