Reduce Time to Market
. . . Achieve Faster Approval
Designing a regulatory strategy or a clinical plan is not just
about timing, logistics and cost controls.
also about pre-empting questions...knowing where the resistance
will come from and working through it.
- It’s also about problem anticipation and planning --
the strategic key to rapid approval.
- It’s also about more than regulatory approval – it’s
about reimbursement, too.
can be managed with foresight or damage can be controlled with
produces effective plans and submissions that achieve the key
result: faster approval.
results to you are improved efficiency, with real value added
at every level, especially straight to the bottom line.
Regulatory strategy development
Protocol review, planning and development
IDE, PMA, 510(k)
FDA advisory committee presentations
International registration dossiers
Regulatory agency liaison