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
episode 3: Season 2: Episode 2 - Pharma Advertising and Promotions: Australia
Pharmaceutical advertisement in Australia is self-regulated or co-regulated, with various bodies having their codes relevant to the promotion of drugs. Our host gives a fair understanding of how the Regulatory environment can present a challenge for ...
episode 2: Season 2: Episode 1 - Pharma Advertising and Promotions: Zimbabwe
A considerable grey area exists between providing information and promoting medicines in a semi-regulated market like Zimbabwe. Our host explores the pharmaceutical laws and regulations laid down by the Medicines Control Agency of Zimbabwe and elabor...
episode 1: Season 2: Episode 0 - Pharma Advertising and Promotions: Introduction
Welcome to Regulatory Radio, brought to you by Freyr Solutions. In the second season, we discuss the ad promo laws and regulations, offering a consolidated and high-level understanding of the laws in regulated and semi-regulated markets. With dynamic...
episode 6: Episode 6. Regulatory Compliance - The Future & Next Steps
Health Authorities have accomplished major milestones in the previous decades. Fast-tracked approval of necessary medical products during the pandemic has set a benchmark for Regulatory Authorities to deliver safe and carefully examined medicines to ...
episode 5: Episode 5. Global & the European Facilitated Regulatory Pathways
Time-to-market plays a major role in addressing the needs of vulnerable patient groups. Facilitated pathways across the globe accelerate the timelines of innovative drug molecules, allowing fast-tracked approval pathways for essential medicines. Our ...
episode 4: Episode 4. Monitoring Medicines and Supervisory Committees
Grant of marketing authorizations signals the commencement of the years-long journey of a drug molecule. Post-market authorization activities begin once the molecule has been approved and is fit to use for the patient population. Inspection of a give...
episode 3: Episode 3. Medicinal Products Lifecycle & Regulatory Pathways
Drug development takes decades of planning and experimentation. Different phases of the drug development lifecycle come with their own unique challenges. Phase-by-phase development of a drug molecule ensures that safe and effective medicines enter th...
episode 2: Episode 2. Centralised and Decentralised Procedures
Different approval pathways can be explored while entering the European pharmaceutical market. The approval pathways include: Centralized Procedure (CP) Decentralized Procedure (DCP) National Procedure (NP) Mutual Recognition Procedure (MRP) Our expe...
episode 1: Episode 1. The European Medicines Regulatory Network
Introduction to the European Medicines Regulatory Network (EMRN) across various functions and procedures. Our experts give an overview of different approval pathways and their significance and elaborate on the different networks available within EMRN...