Freyr Solutions: Recent Episodes
Freyr Solutions
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.Freyr is a trusted partner, providing end-to-end Regulatory services across 8 of the Forbes* Global Top 10 Healthcare / Life Sciences, Mid-market $1+ Billion BioPharma, and Several Small-Medium, Fast Growing Life Sciences companies, CROs, and Standards agencies.Freyr is one of the few global companies to have pioneered specialized Centers of Excellence (CoEs) exclusively focusing on the entire Regulatory value-chain which are supported by rapidly growing global teams of 1200+ Regulatory Professionals.Quick FactsStrategic Regulatory Solutions & Services Partner to:850+Clients8Forbes Global Top 10 Drugs & Biotechnology Companies3Forbes Global Top 10 Health Care Equipment & Services4Forbes Global Top 10 Household & Personal Product Companies2Forbes Global Top 10 Food & Drink Companies85+Innovator Pharma Companies140+Medical Device Companies40+Bio-Tech / Bio-Similar Companies220+Consumer Companies(Cosmetics / Food and Food Supplements)110+CROs / Consulting Companies155+Generic Companies / API Manufacturers
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 the general population. Such efforts have set into motion a cascade of innovation and experimentation in the future of regulations and compliance. Our experts discuss diverse possibilities and innovations in the Regulatory life sciences space.
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 the patient population. Our experts talk about the phases of the drug development lifecycle from the very initial phase to the end, with a view of simplifying the complex stages of drug development.
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 for drug approvals.
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 experts discuss the most explored pathways, CP and DCP, and the eligibility criteria to pursue them for product approval and marketing authorization within the European Union (EU).
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 experts address the necessary requirements of innovators and elaborate on the facilitated Regulatory pathways.
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 given drug product is of prime importance to keep patient safety at the very core. Our experts express their views regarding monitoring medicines and the supervisory committee within the EMRN.
Swiss AR stands for Swiss Authorized Representative, also referred to as CH-REP. Medical device manufacturers located outside Switzerland and without any local business offices shall appoint a Swiss AR on their behalf as a prerequisite for device registration and to launch their device in Switzerland.