Q&C Services’ Post

Facing challenges with Medicine Registration in Post-Brexit UK? 🇬🇧 Discover the MHRA’s New International Recognition Procedure (IRP) for a streamlined path to market. Explore its dual assessment routes and navigate the regulations with ease. Learn about the benefits of the IRP and how it can assist you in the process of Medicine Registration in the UK. https://lnkd.in/eHZ53sAM For further assistance, please message me. #MHRA #Brexit #IRP #MedicineRegistration #UKRegulations #Pharmaceuticals #RegulatoryAffairs #HealthcareInnovation #PharmaIndustry #DrugApproval #UKPharma #internationalrecognition

FDA CDRH 2023 Report: Short Summary 1. Breakthrough Device designation to 167 devices 2. 29 out of 167 received marketing authorization 3. Voluntary Safety Device Program (STdP) established with 15 devices enrolled 4. Three draft guidance in 2023 to support medical device innovations 5. Proposed rule to ensure effectiveness of LDTs (Laboratory Developed Tests) 6. Draft International Harmonization Strategic Plan for Alignment of Regulations and Standards #regulatoryaffairs #regulatory #regulatorycompliance #pharma #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #clinregpartners https://lnkd.in/ghx_5hvN

This week the Council of the European Union adopted the agreement to review the European Medicines Agency fee system. The new regulation: ➡️ Establishes the transition from a flat-rate to a cost-based fee system, ➡️ Provides a sound financial basis between EMA’s support and national competent authorities, ➡️ Makes the system more flexible to future needs by introducing the option to adapt fees, ➡️ Simplifies the existing legislation and merges the content of the two current regulations for pharmacovigilance and non-pharmacovigilance fees into one single legal instrument. The regulation will be published in the Official Journal of the EU and become applicable on 1 January 2025. https://bit.ly/4bfnlXt #pharma #pharmaceutical #healthcare

NEW BLOG... Most of us will know that it is illegal to promote prescription only medicines (POMs) to members of the public, however, it is always worth a reminder that you must be careful what you advertise. READ MORE... https://bit.ly/4d1RZUp CONTACT US: 01252 375362 https://lnkd.in/ez8zhDUu #COGENT #RP #responsibleperson #pharmacycourses #quality person #GDP #Pharmacy #Pharmacyhour #pharmaceutical #Responsibleperson #MHRA #Productsecurity #qualtymanager #pharmacymanager #pharmacyowner #Storage #Transportation

📢 New Blog Post Alert: Are You Ready for EAEU? Countdown to the Deadline – December 31, 2025. Explore the current status and be prepared to navigate the #EAEU regulatory landscape with expert insights and recommendations by Nargiz Asgarova, RegBridge’s Chief Executive Officer. Key Highlights: 🔹 Overview of EAEU regulatory framework and latest updates. 🔹 Current challenges in harmonizing regulatory practices and the risk of drug shortages. 🔹 Detailed action plan to ensure compliance. 🌐 Read the full blog post here: https://lnkd.in/eVbYQhcr #RegBridge #RegulatoryAffairs #HealthcareCompliance #Pharmaceuticals #MedicinalProducts #RegulatoryUpdates #IndustryInsights #DrugSafety #HealthcareRegulations

📢The Food and Drug Administration has released a guidance for industry titled “Controlled Correspondence Related to Generic Drug Development”.   📝This comprehensive Guideline outlines the procedure for generic drug manufacturers and related stakeholders to submit controlled correspondence to the FDA, seeking vital information concerning generic drug development.   🔍The guidance delineates the FDA’s process for communicating responses to such inquiries, ensuring clear and efficient communication channels. Additionally, it details the procedure for requesting clarification on any ambiguities in the FDA's responses, emphasizing transparency and understanding.   This guidance represents a significant revision of the previous version issued in December 2020.   #FDA #GenericDrugDevelopment #Guidance #Innovation #PublicHealth #IndustryUpdates #Pharmaceuticals #Healthcare #FDARegulations

Are You Ready for #EAEU? Countdown to the Deadline – December 31, 2025. If you’d like to know more about EAEU regulatory framework, latest regulatory updates, current challenges and whether Pharmaceutal industry be able to align with EAEU regulations by December 2025, as well as get Step-by-Step Guide and detailed Check-list for Upgrade procedure - check out my New Blog Post below 👇: 🌐 https://lnkd.in/eyfes6tK RegBridge | #Regulatory beyond borders #RegulatoryAffairs #RegulatoryUpdates #IndustryInsights #PharmaRegulation #RegulatoryCompliance

Our March Case Study is now ready for you to download as a PDF. A 7-minute read worthwhile to understand how we support our customer to navigate the transition of a greenfield site. #pharmaceutical #itot #digitaltransformation #compliance #biopharma #itoperations #managedservices

Our first case study from Q1 2024 is now available as a PDF. Feel free to download and understand: What is involved when moving from a greenfield site to full-scale operations. How to address both IT and OT during the delivery of support. The impact of regulations and FDA guidance on the priorities. Find the associated blog and much more here: https://lnkd.in/eBD6smsG Happy Reading! #pharmaceuticals #biopharma #pharmalab #ITOT #ITOTgap #ITOTconvergence #digitaltransformation #CDS #itoperations

💊 Just before the end of 2023, Reuters published an article breaking a story from data analyzed by 3 Axis Advisors, a healthcare research firm. The analysis evaluated anticipated drug price hikes in the coming month, revealing that approximately 500 drugs of varying doses and formulations from over 140 brands are expected to increase their list prices in January 2023. For example, Pfizer is projected to have the most significant number of January drug price increases, accounting for 25% of the anticipated increases. Overall, Pfizer intends to increase the cost of 124 drugs and 22 additional drugs through Hospira.🌐💡 #HealthcareNews #DrugCosts #MedicalUpdates #PrescriptionPrices #HealthAlert #StayInformed #Pharmaceuticals #DrugPricesRise #HealthcareCosts #MedicalInsights #HealthcareChanges #DrugIndustry #PatientCare #HealthcareAwareness #PrescriptionMedication #HealthcareCommunity #MedicalCosts #WellnessJourney #HealthcareNow #DrugAffordability #HealthcareImpact #MedicalNews #HealthcareUpdates #PrescriptionDrugs #DrugMarket #CostOfMedicine #PharmaIndustry