This week, the spotlight is on the Nordics with two exciting events in Finland and Sweden! 🌟 🔹 Healthtech Export Day | August 28, 2024 | Helsinki, Finland 🎙️ Tiina Riihimäki 🔗 Learn more: https://lnkd.in/gJubTwTN 🔹 The Future of Swedish & Danish Life Science Conference 2024 | August 29, 2024 | Lund, Sweden 🎙️ Kenneth Hollmén & Christine Mellborg 🔗 Learn more: https://lnkd.in/dfxqUPA7 Join us to connect with industry leaders and grow your network. #PharmaLexInTheField #PharmaLex #Events #GlobalExpertise #IndustryEvents #Networking #Nordics
PharmaLex
Arzneimittelherstellung
Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains
Info
PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance, Pharmacovigilance, Epidemiology, and Risk Management worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. Through our worldwide offices, we provide flexible and cost-effective service models. Looking for local expertise with global reach? Contact us, to find out more!
- Website
-
http://www.pharmalex.com
Externer Link zu PharmaLex
- Branche
- Arzneimittelherstellung
- Größe
- 1.001–5.000 Beschäftigte
- Hauptsitz
- Bad Homburg
- Art
- Privatunternehmen
- Gegründet
- 1994
- Spezialgebiete
- Regulatory Affairs, Pharmacovigilance, Regulatory Operations, Pharmaceutical Quality, Audit / Inspection Preparation, Medical Writing, Biostatistics, Medical Devices, Risk Mangement, Development Consulting, GxP services und Clinical Trial
Orte
Beschäftigte von PharmaLex
Updates
-
Are you facing challenges in your Quality Assurance (QA) organization? At PharmaLex, we understand the complexities and demands of the pharmaceutical industry, especially in the Nordic region. Whether you're dealing with resource shortages or navigating the intricate regulatory landscape, we're here to help. ▪ Struggling with a lack of team members experienced in Nordic supply chain and GDP-related regulatory demands? ▪ Unsure about the special requirements for importing goods into Finland? ▪ Need support for your Marketing Authorization (MA) acquisition or transfer, including WDA licenses, Responsible Person (RP), and Quality Management Systems (QMS)? Don't let these challenges slow you down. Reach out to PharmaLex today and let our experts guide you through the process with tailored solutions that meet your needs. Connect with us now to ensure compliance and streamline your operations. 🔗 https://lnkd.in/gpVm8W2 #Pharma #Pharmaceuticals #QualityAssurance #NordicSupplyChain #RegulatoryAffairs #GDP #WDA #QMS #PharmaLex #RP
-
Join us at the PIPA Conference 2024 – Pharmacovigilance Day! 📅 Date: September 18th, 2024 📍 Location: Radisson Edwardian Blu Hotel, Heathrow A day dedicated to pharmacovigilance and medical information, offering a focused agenda and networking opportunities to support PIPA members’ interests and development. Meet our team: 🌟 Cheryl James, Director Pharmacovigilance 🌟 Dora Amene, Associate Director, Pharmacovigilance 🌟 Abdullah Yassin, Business Developer Manager Don’t miss out! Register now: https://lnkd.in/eSWufMru #PharmaLex #PIPAConference2024 #MedicalInformation #Networking #Pharmacovigilance #PIPAMembers
-
We excel at helping our customers understand and meet the regulations and guiding them efficiently through remediation activities. Our QMC expert, Londa R., consistently delivers on time and on budget with exceptional client accolades. 💬 Client Testimonial: “We appreciate your feedback and your mindfulness in helping us use the remaining time on the work order efficiently. Our partnership with you and everyone at PharmaLex has been invaluable and we truly appreciate your support.” Discover more about our Quality Management and Compliance services: https://lnkd.in/e_2XZwqt Contact us to discuss your QMC project: https://lnkd.in/ebycGVSJ #HappyClients #PharmaLex #PharmalexUS #QualityManagement #Compliance #ClientSuccess #QMC #PharmaExcellence
-
Discover the latest trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry. Dive into Patrick Nieuwenhuizen’s expert analysis on how advancements and regulatory changes are shaping the future of pharma. Read here: https://lnkd.in/dQHEgnWt #PharmaLex #AsepticProcessing #IsolatorTechnologies #Innovation #Sterility #FDA #EMA #Sustainability
-
🚀 Unlock the secrets to improving safety reporting speed and accuracy in our exclusive on-demand webinar! Watch industry leaders Karin van Dort and Tim Billington as they delve into innovative strategies and real-world case studies. Discover how companies are leveraging intelligent process automation and embedded regulatory intelligence to: 🔍 Enhance the speed, accuracy, and consistency of safety reporting 🤖 Automate end-to-end distribution and tracking processes 📊 Obtain real-time oversight and detailed reporting 💼 Improve regulatory compliance and site responsiveness rates Watch now this webinar and streamline your safety reporting processes to maximize efficiency! 🔗https://lnkd.in/dZTFrtUq #PharmaLex #Webinar #SafetyReporting #RegulatoryCompliance
-
🔔 Don't miss out on valuable insights! Watch our on-demand webinar with Louise Uí Fhatharta Fhatharta on "Preparing for Success: How to Ensure a Successful Health Authority Inspection." Learn how to take a proactive approach to inspections and identify key elements of regulatory noncompliance. Watch now: https://lnkd.in/dJyWTNkt #PharmaLex #OnDemandWebinar #HealthAuthorityInspection #RegulatoryCompliance
-
The shift to the EMA’s Product Management Service (PMS) is here, and it’s crucial for marketing authorization holders to stay ahead. In our latest blog, Clara Borao, Manager in Regulatory Informatics Services at PharmaLex, dives deep into what this transition means for the industry and the steps you need to take to ensure compliance. Discover more about the Union List of Critical Medicines (ULCM), the significance of precise product information, and strategies for navigating the evolving regulatory environment. Read the full article here: https://lnkd.in/d9FYMQ2Z #PharmaLex #EMA #PMS #RegulatoryAffairs #Pharmaceuticals #Compliance #Healthcare #Medicines #DataManagement #PharmaIndustry
-
#InnovationsToMarket 🚀 // At PharmaLex, our dedicated team excels in guiding clients through the intricate journey of drug development and regulation. We prioritize delivering excellence, ensuring adherence to stringent global regulatory standards every step of the way. With a footprint spanning over 40 nations, our impact is truly global. Join us in shaping the future of the pharmaceutical landscape. Learn more 🔗 https://lnkd.in/de8HeD-H #PharmaLex #PharmaIndustry #GlobalReach #RegulatoryAffairs #QualityAssurance #Compliance #Pharmacovigilance #RegulatoryExcellence
-
Explore our latest article, where Christopher Rogers breaks down the recent revisions to ICH Q2(R2) and ICH Q14, shedding light on the new guidance for analytical methods in biologics. Key takeaways: 1️⃣ Flexibility in Methodology: The guidance supports deviations from standard methodologies when justified. 2️⃣ Analytical Development Lifecycle: Emphasis on the importance of suitable analytics for IND applications and Phase III/BLA. 3️⃣ Clarity and Detail: Enhanced detail and specific examples in Annex 2, aiding in technique interpretation. 4️⃣ Risk-Based Approach: ICH Q14 introduces a structured, risk-based methodology for assay development. 5️⃣ Advanced Analytical Procedures: Frameworks for mass spectrometry and spectroscopic techniques ensure continuous improvement. Dive into the full article for more insights: https://lnkd.in/dJCb7vEJ #Biologics #RegulatoryAffairs #PharmaLex #ICHQ2 #ICHQ14 #AnalyticalMethods #ChristopherRogers