• Season 3 - Regulatory Roadmap to the US Market Entry

    What is it all about?

    Welcome to Freyr’s Regulatory Radio - a careful curation of podcasts that suit your curious taste palate for all things related to Life Sciences regulations. Our one-of-a-kind Regulatory podcast series strives to streamline the complex positioning of pharmaceutical regulations. The series ranks first in priority on the “to be heard” list of podcasts for Regulatory Affairs professionals involved in strategy, submissions, and operations.

    In the third season, we will be discussing the regulations by the US FDA – with a key focus on human drug regulations and the landscape of Regulatory Affairs in a region that sets the benchmark for Life Sciences innovation worldwide. The episodes introduce the US Market Entry Strategy that highlights the legacy of facilitated pathways, the GDUFA guidelines, and much more.

Meet Our Speakers


Ester Brown

Director, Americas Business Development

Ester is a Director at Freyr with over twenty (20) years of work experience. She is a skilled collaborator with more than six (06) years of expertise supporting the Life Sciences industry as a commercial business partner. She has experience across multiple focus areas (Pharma, Medical Devices, Biotech, etc.) with clients ranging from global companies to start-ups. She assists customers to help navigating their Regulatory requirements and addressing challenges from pre-submission to post-market across the entire Regulatory value chain. Ester is well-positioned to leverage Freyr's global Regulatory solutions, services, and technology innovations toward achieving client goals and requirements.


Wasi Akhtar

Head of Presales and Solutioning, Senior Manager II, Medicinal Products

Wasi has over twelve (12) years of professional experience in various regulated industries and has extensive expertise in strategic consulting and solutions. Wasi specializes in both services and cloud-based software solutions.