Phortas

🚀Case Study: Turning Regulatory Challenges into Approvals 🚀 Phortas recently stepped in to support an EU-based biotech client facing critical regulatory hurdles in their CTIS application for a Phase 1 trial. When unexpected regulator questions emerged, putting the trial's approval at risk, our team provided immediate, ad-hoc regulatory support. We identified and clarified existing data, enhanced document presentation, and even drafted a missing core document in collaboration with the client—all within extremely tight timelines. This strategic and rapid response led to the trial's approval, underscoring our commitment to turning regulatory challenges into successful outcomes. #CTIS #regulatoryaffairs #biotech #pharmaceutical #pharma #drugdevelopment #regulatorysubmission #casestudy #phortas

📢 The Duke-Margolis Institute for Health Policy, with the FDA, is hosting a virtual workshop on innovative strategies for dose optimization on 29-Oct-2024. Our Director and Senior Regulatory Lead Dr. Darius-Jean Namdjou , will attend this workshop. 🧬 Background: There are over 10,000 rare diseases affecting around 30 million individuals in the U.S., yet only a small fraction have approved treatments, leaving significant unmet needs. Clinical trials for rare diseases face unique challenges, including small patient populations, disease heterogeneity, and lack of established regulatory endpoints, impacting key drug development steps like dose-finding. Dose-finding studies, essential for determining safe and effective dosing, are particularly complex in rare diseases due to varying clinical features, onset ages, and disease severities. Conventional dose-finding approaches often fall short, necessitating more patient-centered methods. Find more info here: https://lnkd.in/eCsyUCPx

Our managing director Jasmina Savic is a part of an excellent team of pharmaceutical professionals who contribute to the selection of the topics and program for the next RAPS EU Convergence! #regulatoryaffairs #raps

Phortas Case Study: Supporting a US-based Pharmaceutical Company in Paediatric Drug Development In one of our key projects, Phortas helped a US-based pharmaceutical company develop their Paediatric Investigational Plan (PIP). With our deep expertise and experience in paediatric drug development, we provided a detailed strategy for their upcoming paediatric clinical trial. Key outcomes of this collaboration: 🔹 Developed a thorough plan for paediatric clinical trials, including study design, target population, and key endpoints. 🔹 Advised on timelines, documentation, and data submission requirements for the EMA. 🔹 Ensured the PIP met the highest standards of quality and regulatory compliance. This project highlights Phortas' ability to deliver tailored solutions that ensure success in regulatory pathways. Our team's expertise and guidance were critical in ensuring that the company's clinical trials were conducted with the best possible outcomes for patients. 📧 For more information or to discuss how we can support your regulatory needs, feel free to contact us at [email protected] #PaediatricDevelopment #PharmaceuticalExcellence #RegulatoryAffairs #EMA #ClinicalTrials #Phortas #biotech #pip

Phortas is thrilled to announce that Dr. Darius-Jean Namdjou, our Director and Senior Regulatory Lead, will attend the Scientific Symposium on Advanced Therapy Medicinal Products (ATMP) at the EMA offices in Amsterdam on October 10, 2024. This event will explore the role of the CAT in shaping the regulatory framework for ATMPs in Europe and discuss the future of these innovative therapies. Attendees will include regulatory authorities, industry experts, and patient representatives. Let’s connect to discuss how Phortas can support you developing your ATMP therapies! [email protected]

🎉 Celebrating 7 Years of Phortas! 🎉 Today marks a special milestone for us at Phortas – we’re celebrating 7 years of dedication, growth, and success in the world of Regulatory Affairs and Drug Development! From humble beginnings to becoming a trusted partner in the pharmaceutical industry, our journey has been defined by innovation, collaboration, and an unwavering commitment to delivering exceptional regulatory solutions. A heartfelt thank you to our amazing clients, partners, and the Phortas team for your support and trust over the years. Your dedication has been instrumental in our growth and success. Here’s to many more years of advancing health, driving excellence, and making a lasting impact! 🚀 #Anniversary #7YearsOfSuccess #Phortas #RegulatoryAffairs #DrugDevelopment #Innovation #Collaboration #ThankYou #Pharma #biotech

📢 Exciting News! Phortas’ Director and Senior Regulatory Lead, Dr. Darius-Jean Namdjou, will be attending the World Drug Safety Congress Europe 2024 in Amsterdam from October 9-10. We are thrilled to participate in this leading event and look forward to connecting with our colleagues and all professionals passionate about advancing drug safety. We are also happy to discuss any Regulatory Affairs and Drug Development topics with you.   🗓️Let’s Connect! Don’t miss the opportunity to meet us at the congress—drop by and say hello, or reach out to schedule a meeting.  info➡️ https://lnkd.in/gj8-pf6 #DrugSafety #WorldDrugSafetyCongress #RegulatoryAffairs #Phortas #Networking #biotech #pharmaceutical

🌟 Exciting News from Phortas! 🌟 We are thrilled to announce that our Managing Director, Jasmina Savic, has been selected to serve on the Regulatory Affairs Professionals Society (RAPS) Euro Convergence Program Committee for a three-year term, with a key focus on the Pharmaceutical track development. 🎯 Her dedication and leadership will undoubtedly contribute to shaping the future of regulatory affairs in the pharmaceutical industry. Congratulations, Jasmina! We are proud of your achievement! 👏 #Leadership #Pharmaceuticals #RegulatoryAffairs #RAPS #EuroConvergence #Phortas

Phortas: Your Trusted Partner for CTIS Submission in the EU Phortas is uniquely positioned to support your CTIS submission in the EU. Our team of international regulatory experts brings extensive experience in handling regulatory submissions of all kinds, including orphan drugs, and clinical trials ranging from single-country to multi-country studies, across Phase I-IV. What sets Phortas apart? We are a customer-centric consultancy, specifically tailored to the needs of small to mid-sized (bio)pharma companies. Our validated processes, SOPs, and work instructions ensure a seamless and compliant submission process. From the very first kick-off meeting through to submission and follow-up, Phortas works closely with sponsors, providing transparent oversight and regular progress updates. With Phortas, you gain a partner dedicated to guiding you through every step of the regulatory journey. Contact us: [email protected] #regulatoryaffairs #drugdevelopment #biotech #pharmaceutical #ctis

Case Study: How Phortas Helped US-Based Biotech Secure ODD in the EU 🧬 When a U.S.-based company needed to accelerate the approval process for a new drug targeting a rare disease, they turned to Phortas for support in Europe. While they had already secured Orphan Drug Designation (ODD) in the USA, the complex European regulations presented a new challenge. See below how Phortas with its SME status helped with ODD and supported a development of a ground breaking stem cells orphan drug. #regulatoryaffairs #drugdevelopment #odd #raredisease #orphandrugs #biotech