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.
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Gesamtlänge aller Episoden: 4 hours 18 minutes
episode 6: Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products
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 responsibili...
episode 5: Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting
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 ver...
episode 4: Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
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...
episode 3: Season 3: Episode 3 - Procedures for Medicinal Products’ Approval
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 ph...
episode 2: Season 3: Episode 2 - GDUFA & PDUFA Guidelines
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.
episode 1: Season 3: Episode 1 - US Market Entry & Landscape In Regulatory Affairs
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.
episode 7: Season 2: Episode 6 - Pharma Advertising and Promotions: Canada
The pharmaceutical advertising in Canada for prescription drugs has always been under scrutiny as laws governing Direct-to-Consumer (DTC) advertisements of prescription-only medicines are misunderstood by organizations. The governing authority for me...
episode 6: Season 2: Episode 5 - Pharma Advertising and Promotions: Mexico
The Mexican pharmaceutical promotional regulations for advertising drugs, governed by the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), are subjected to specific requirements to protect Healthcare Professionals (HCPs) and cons...
episode 5: Season 2: Episode 4 - Pharma Advertising and Promotions: United Kingdom
Post-Brexit, the United Kingdom’s advertising review team scrutinizes published advertising in selected media, and we investigate referrals from colleagues in the Agency or other Regulatory Authorities. Our host addresses the necessary pharmaceutical...
episode 4: Season 2: Episode 3 - Pharma Advertising and Promotions: Lithuania
The Republic of Lithuania reflects good economic fortune for medicine manufacturers’ regional investments. To explore the Lithuanian market, manufacturers must obtain approvals from the State Medicines Control Agency. Our host gives us an insight int...