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
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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 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 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 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 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...
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