Freyr Regulatory Radio
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.
Episodes
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 responsibilities and ensuring you stay compliant.
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 also empowers you to understand and implement MoCRA safety requirements and MoCRA safety substantiation.
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 professional or just stepping into the Regulatory arena, this episode is a must-listen for anyone seeking clarity on MoCRA's product listing mandates.
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 simply curious about the industry, this episode is your essential guide to understanding MoCRA's key players. Tune in and gain clarity on MoCRA's RP and US Agent.
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 requirements fosters trust and builds a strong foundation for your cosmetic brand's success in the US.
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.
Furthermore, this episode throws light upon the criteria for the reference biological products and its evaluation.
To know more about Season 4, visit: https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products
Streamlined biologic product development involves proper Regulatory assessment and overcoming challenges encountered during the CMC development phase. This episode will discuss the challenges faced during complex biological product development.
Furthermore, our experts will express their Regulatory views on variability in batch-to-batch testing, impurities testing, viral load clearance, and factors encountered in the biological pro...
Biological product development involves proper planning and experimentation. Comprehending the biological CMC requirements is one such critical aspect during its development. This episode will detail the specifications required during biologics/biosimilar development.
Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details.
Episode 2 will detail the various guidelines for biological product development and approval in the market. The reference guidelines discussed in the podcast will include the following:
- Guidelines that describe the expression construct, cloning, cell bank preparation, and characterization of biological products.
- Guidelines to be referred for biologics drug substance development and manufacturing.
- Guidelines to be referred for v...
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 significance and requirements of Regulatory submissions and scientific advice during the Regulatory processes.
To know more about the Season 4: EU Regulatory Pathways for Biological Products, visi...
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.
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.
To know more about Season 3, visit https://www...
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.
To know more about Season 3, visit https://www.freyrsolution...
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.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry
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.
To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry
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. To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry
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 medicines, Health Canada, is responsible for general advertisement and promotions. Our host highlights the laws and regulations laid down by Health Canada.
Tune into other episodes of ...
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 consumers from any associated risks. In this episode, our host describes the general requirements of drugs from an advertising perspective, legislated and issued by the Code of Conduct.
Tu...
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 advertising regulations a pharmaceutical organization must follow to ensure that the advertising material is thoroughly reviewed before the issue, thus avoiding misleading messages and...
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 into the Regulatory framework involved in the successful advertising and promotion of medicines.
Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/seaso...
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