Stay updated on MHRA's latest guidance for clinical trial authorization in the UK dated April 10, 2024. Ensure compliance and streamline your application process with our experts at Freyr. Book a slot today. https://lnkd.in/gjtPYEAB #MHRAGuidance #ClinicalTrialAuthorization #ApplicationProcess #FreyrSolutions #RegulatoryCompliance
Freyr Global Regulatory Affairs
Pharmaceutical Manufacturing
princeton, New Jersey 5,690 followers
Regulatory Assessment, Market Authorizations, Post-Approval Changes, HA Query Management.
About us
Freyr offers comprehensive global Regulatory services for new product and market authorizations, post approvals, CMC, and lifecycle management. Our pragmatic solutions help companies maximize their product's commercial potential and market success. With expertise in New Product Authorizations, Post Approval, Regulatory Consulting, New Market Authorizations, and Health Authority Queries, Freyr helps Life Sciences, Consumer Pharma and Bio-Med companies understand and efficiently manage diverse Regulatory requirements to launch their products in new markets and maximize asset value. Feel free to browse our page for more information on our services and expertise. You can also reach out to us directly through LinkedIn messaging or by visiting our website. We look forward to hearing from you and helping your business succeed in today's global marketplace. Our Vision “To be the essential partner to manage global Regulatory complexity and market safe and compliant products in local countries.” In order to succeed, we must first believe that we can, and we strongly believe the future is not something we enter, it is something we create. And we are here to create a compliant pathway for our customers’ global market entry. Quick Facts • 180+ REGULATORY EXPERTS. • 15000+ PROJECTS • 100+ COUNTRIES • 200+ PRODUCTS • 250+FORMULATIONS • 9 Forbes Global Top 25 Pharma Companies • 5 Forbes Global Top 15 Biotech Companies • 60+ Mid and Small Pharmaceutical companies • 25+ Mid and Small Bio-Tech / Bio-Similar Companies
- Website
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https://regulatoryaffairs.freyrsolutions.com/
External link for Freyr Global Regulatory Affairs
- Industry
- Pharmaceutical Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- princeton, New Jersey
- Specialties
- Pharmaceuticals and Regulatory Affairs
Updates
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The US FDA's latest guidelines on 'Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies' aim to streamline the process of safety reporting for IND-exempt BA/BE studies and enhance pharmacovigilance efforts. Learn more about such updates from our experts. Contact us now. https://lnkd.in/gjtPYEAB #USFDAGuidelines #BABEStudies #SafetyReports #INDExemptStudies #FreyrSolutions
Comprehend USFDA's Latest Guidance on Expedited Safety Reports From IND-exempt BA/BE Studies Contact Our Experts Now
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ANVISA's groundbreaking call for health startups in Brazil offers a chance to pioneer innovation in drug development, accelerating access to vital treatments. Stay informed about the latest developments with just a single click. Reserve your spot now for expert guidance and support. https://lnkd.in/gjtPYEAB #ANVISA #HealthStartups #DrugDevelopment #VitalTreatments #FreyrSolutions
Understand ANVISA's Nitrosamine Risk Guidance Get Expert Assistance Today
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The new MHRA guidance urges Marketing Authorization Holders to address nitrosamine risks in medicinal products, emphasizing thorough risk evaluation and confirmatory testing. Stay compliant and prioritize patient safety with Freyr. Contact us today for expert assistance to ensure compliance. https://lnkd.in/gjtPYEAB #MHRA #MAH #NitrosamineRisks #RiskEvaluation #PatientSafety #FreyrSolutions
Ensure Compliance with the New MHRA's Guidance On Nitrosamine Risks Contact us Today
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The US FDA proposes Patient Medication Information (PMI) to improve clarity for prescription drug users. PMI offers concise, easy-to-read info to help patients understand their meds better. Learn more about this proposed FDA guidance from our experts. Schedule an appointment today. https://lnkd.in/gjtPYEAB #PMI #PrescriptionDrugs #USFDA #SafetyInformation #FreyrSolutions
Understand FDA's Latest Proposal on PMI Schedule an Appointment Now
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On-time submission of Q5 PADER to the US FDA. Decode how Freyr partnered with a US-based generic drug manufacturer to review and prepare PADER submissions to the US FDA. Download the proven case. https://lnkd.in/gU3sxuBD #PADERSubmissions #USFDA #pharmaceuticals #Q5PADER #RegulatoryAffairs #CaseStudy #ProvenCase
On-time Submission of Q5 PADER to the US FDA
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Unlock Regulatory Success with Templatized CTD Dossier Templates! Dive into our carousel for insights on streamlining Regulatory submissions. From INDs to MAAs, Freyr offers tailored templates for seamless approvals. Elevate your Regulatory strategy today! https://lnkd.in/gp8BabwS #RegulatoryCompliance #Pharma #Biotech #RegulatoryAffairs
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Dive into EMA's Post-Authorization Procedures for Market Authorization Holders! Learn key insights on variations, renewals, and more in our latest blog. Plus, discover how Regulatory service providers streamline compliance, ensuring product safety every step of the way. Don't miss out! https://lnkd.in/g4yMPcZD #EU #EMA #RegulatoryCompliance #PharmaSafety
Comprehending EMA’s guidance for Post-Authorization Procedures
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ANVISA has extended the deadline for submitting drug marketing reports until March 31, 2024. Ensure timely submission via Sammed to adjust prices for 2024. Streamline your report submission process with Freyr. Contact us today for expert assistance to ensure compliance. https://lnkd.in/gjtPYEAB #ANVISA #publishingandsubmissions #Compliance #Freyrsolutions
Meet ANVISA's Deadline with Freyr's Expertise Contact Us for Assistance Now
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The US FDA's latest draft guidance on Real-World Evidence provides recommendations for sponsors and investigators on conducting non-interventional studies to support the effectiveness and safety of drugs. It discusses study design, data sources, and analytic approaches. Learn more about such recommendations from our experts. Contact us now. https://lnkd.in/gjtPYEAB #Freyrsolutions #RWE #USFDA #Pharmaceuticals #Regulatoryaffairs
Unlock US FDA's Real-World Evidence Draft Guidance Connect for Insights Today
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