The US Food and Drug Administration (FDA) and European Medical Agency
(EMA), as well as other regulatory agencies throughout the globe have product
commercialization requirements that evolve constantly in tandem.with technological advances, as well as public health needs. In the US
market, three evolving areas from FDA’s perspective are the evolution of the 510(k) premarket notification process, regulation of specific rare diseases, and advertising and promotional regulation(s). tJûn17 Life Sciences Advisors will help you to apply current global regulatory guidelines to maximize your chance for product marketing approvals and to minimize time to peak sales. In addition, we will support you in your submission of compliant regulatory applications and documentation to global regulators and a wide array of other stakeholders.
A product commercialization plan for sustaining unique and superior competitive advantages in today’s global medical technology market starts with a well researched and comprehensive regulatory strategy.