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.

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5 days ago

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: 

Tuesday Sep 19, 2023

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 product arena.
To know more about the Season 4, visit: 

Tuesday Sep 12, 2023

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. 

Tuesday Sep 05, 2023

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 viral safety evaluation and analytical method validation of the products.
Stability management of biological products.
Our Regulatory experts will share more details about the subsidiary guidelines to be referred by a pharma company for streamlining Biologics development.

Monday Aug 28, 2023

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, visit: 

Tuesday Feb 28, 2023

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.
To know more about Season 3, visit  

Tuesday Feb 21, 2023

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 

Tuesday Feb 14, 2023

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 

Tuesday Feb 07, 2023

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 

Tuesday Jan 31, 2023

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 

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