Freyr Regulatory Radio
En podcast af Freyr Solutions
29 Episoder
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Season 5: Episode 5 – Reporting Adverse Events Under MoCRA
Udgivet: 1.3.2024 -
Season 5: Episode 4 – Safety in Focus – MoCRA Safety Substantiation
Udgivet: 1.3.2024 -
Season 5: Episode 3 – Mastering Product Listing: A Comprehensive Guide to MoCRA Requirements
Udgivet: 1.3.2024 -
Season 5: Episode 2 – Untangling the Responsibilities of MoCRA Agents and RPs
Udgivet: 1.3.2024 -
Season 5: Episode 1 – MoCRA Facility Registration: What You Need to Know?
Udgivet: 1.3.2024 -
Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU
Udgivet: 26.9.2023 -
Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars
Udgivet: 19.9.2023 -
Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars
Udgivet: 12.9.2023 -
Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars
Udgivet: 5.9.2023 -
Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU
Udgivet: 29.8.2023 -
Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products
Udgivet: 28.2.2023 -
Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting
Udgivet: 21.2.2023 -
Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
Udgivet: 14.2.2023 -
Season 3: Episode 3 - Procedures for Medicinal Products’ Approval
Udgivet: 7.2.2023 -
Season 3: Episode 2 - GDUFA & PDUFA Guidelines
Udgivet: 31.1.2023 -
Season 3: Episode 1 - US Market Entry & Landscape In Regulatory Affairs
Udgivet: 24.1.2023 -
Season 2: Episode 6 - Pharma Advertising and Promotions: Canada
Udgivet: 14.12.2022 -
Season 2: Episode 5 - Pharma Advertising and Promotions: Mexico
Udgivet: 7.12.2022 -
Season 2: Episode 4 - Pharma Advertising and Promotions: United Kingdom
Udgivet: 30.11.2022 -
Season 2: Episode 3 - Pharma Advertising and Promotions: Lithuania
Udgivet: 23.11.2022
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.
