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
- 1
- 1
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...
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 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 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 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 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 ...
- 1
- 1