A vision without a strategy remains an illusion.
A successful regulatory strategy demands a commercial approach that targets the broadest, most competitive product attributes that are aligned with the development science and clinical positioning.
We work with you to confirm the regulatory requirements and define the pathways to regulatory approvals and reimbursement. We are experienced at regulator pre-consultations to remove the unknowns and de-risk the project.
In a global industry, strategy must be international. A well-developed strategy targets the prime markets and then utilises these initial approvals to support accelerated secondary market access.
Even in an era of harmonisation, local regulations vary widely. The art is in building comprehensive understanding of technical requirements and standards and matching these to the various regulatory processes. We help you to build a core data set for multiple international product registrations and reimbursements.
At a Glance:
Product positioning and claims
Regulatory and reimbursement pathways (one or multiple markets)
Technical requirements and standards
Pre-consultations (including US, China, Europe, Australia)
Global market access planning