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.
Introduction to the USFDA framework and the cascade of events ultimately lead to authorization to market a drug product. Our experts elaborate on every department under the US FDA, focusing on the CBER and the CDER.
Establishment of the GDUFA and PDUFA guidelines and their impact on innovators and generics. Our experts discuss various merits of the guidelines and the significant changes signed into the law with each latest amendment.
Understanding the unique benefits of standard drug approval pathways by the US FDA. Our experts talk about the importance of the different stages of drug development, right from the drug discovery/conceptual phase, pre-clinical phase, and clinical phase to the FDA review.
Expedited drug development pathways ensure the availability of treatment at the earliest. The US FDA’s facilitated Regulatory pathways give priority to innovators based on the nature of their innovation and more. Our experts discuss (i) Fastrack, (ii) Breakthrough Therapy, (iii) Accelerated Approval, and (iv) Priority Review and their impact on drug development timelines.
Patents are non-tangible assets for an organization/individual. To safeguard the innovator’s rights, the US FDA follows a unique patenting pathway for innovations. The United States Patent and Trademark Office (USPTO) looks after the awarding and verification of Intellectual Proprietary Rights. Our experts enlist various exclusivity periods stated under different designations and more.
The Regulatory Affairs Life Cycle Management of a drug is considerably different from other commodities. The Office of the Lifecycle of Drug Products, a department under the Office of Pharmaceutical Quality (OPQ) under CDER, oversees the responsibility of delivering quality medicines to the population. Our experts elaborate on the subdivisions and their responsibilities toward the safety and efficacy of medications.
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.
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.