Freyr is a leading, niche, full-service global Regulatory Solutions, and Services Company supporting, Large, Medium, and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Food and Food Supplements | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.
https://freyrsolutions.podbean.com
Gesamtlänge aller Episoden: 4 hours 18 minutes
episode 5: Season 5. Episode 5 – Reporting Adverse Events Under MoCRA
MoCRA brings significant changes to the way adverse events associated with cosmetic products are reported in the US. This episode delves into the nitty-gritty of MoCRA's adverse event reporting requirements, helping you understand your responsibiliti...
episode 4: Season 5. Episode 4 – Safety in Focus – MoCRA Safety Substantiation
MoCRA raises the bar for cosmetic safety and demonstrating "adequate substantiation" is key. But what exactly does that mean? This episode unlocks the secrets of MoCRA safety substantiation, guiding you through the process with expert insights. It al...
episode 3: Season 5. Episode 3 – Mastering Product Listing: A Comprehensive Guide to MoCRA Requirements
In today's episode, we're embarking on a deep dive into MoCRA's product listing requirements. We'll unravel what this entails, who exactly needs to adhere to it, and the crucial information that must be included. Whether you're a seasoned industry pr...
episode 2: Season 5. Episode 2 – Untangling the Responsibilities of MoCRA Agents and RPs
This episode untangles the role of the Responsible Person (RP) and the US Agent. We'll break down their key differences and responsibilities, ensuring you stay compliant and navigate the market smoothly. Whether you're a manufacturer, distributor, or...
episode 1: Season 5: Episode 1 – MoCRA Facility Registration: What You Need to Know?
Understanding MoCRA's Facility Registration requirements is crucial for cosmetic manufacturers. It ensures transparency and product safety, paving the way for smooth operations in the US market. Compliance with MoCRA's facility registration requireme...
episode 5: Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU
In the last episode of Freyr Regulatory Radio, Season 4, our experts discuss key considerations for Comparative Quality Studies for a proposed biosimilar product in the EU.
episode 4: Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars
This episode will discuss the challenges faced during complex biological product development.
episode 3: Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars
Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details.
episode 8: Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars
Episode 2 will detail the various guidelines for biological product development and approval in the market.
episode 1: Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU
Introduction to Biologics and Biosimilars is the core of this episode. Our Regulatory experts will give an overview of the different Regulatory approval pathways for Biologics and Biosimilars in the EU. Additionally, they will discuss the significanc...