AzurBio Pharma expands its European regulatory services with the acquisition of A-pharmaconsult. We are glad to announce that AzurBio Pharma has acquired A-pharmaconsult, a leading European regulatory consultancy with over 30 years of experience. This marks a significant milestone in our journey to becoming a key partner for life sciences companies across Europe. As a result of this strategic alliance, we are launching AzurBio Consulting, a new brand dedicated to providing tailored strategic and operational consulting services for pharmaceutical, biotechnology, and medical device companies. 💡 Why is this important? By combining A-pharmaconsult’s renowned regulatory expertise with AzurBio Pharma’s innovative and agile approach, we are strengthening our ability to support companies throughout the entire healthcare product lifecycle—from development to commercialization. 🔹What AzurBio Consulting Offers: ✅ European development & regulatory strategy ✅ Scientific writing & regulatory submissions ✅ Quality management solutions ✅ End-to-end support in navigating complex regulatory landscapes Learn more: www.azurbio-consulting.com 📩 Contact us: [email protected]
AzurBio Pharma
Recherche en biotechnologie
Paris, Île-de-France 1 041 abonnés
AzurBio Pharma tackles biopharma's challenges of introducing their 1st life-changing medicine to Europe.
À propos
AzurBio Pharma is the partner of choice for biopharma companies looking to launch their innovation in rare or serious diseases in the European market. With a dual presence in the US and Europe, we are supporting North American companies to access the EU market by maximizing flexibility and minimizing operational burden.
- Site web
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https://azurbio-pharma.com/
Lien externe pour AzurBio Pharma
- Secteur
- Recherche en biotechnologie
- Taille de l’entreprise
- 2-10 employés
- Siège social
- Paris, Île-de-France
- Type
- Société civile/Société commerciale/Autres types de sociétés
- Fondée en
- 2022
- Domaines
- biopharmaceuticals, regulatory compliance, rare diseases et orphan products
Lieux
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Principal
32, Avenue Kléber
75116 Paris, Île-de-France, FR
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62 William Street
8th Floor
NY10005 New York, New York, US
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230 route des Dolines
06560 Sophia Antipolis, FR
Employés chez AzurBio Pharma
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Thierry Souchon
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Nadia Boehringer
Chief Operating Officer Europe | MSc | Global Executive MBA | Leadership & Project Management in accelerating drug patient access
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To-Quynh Gandolphe
Directrice des affaires pharmaceutiques et réglementaires - Pharmacien Responsable chez AzurBio Pharma
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Sophie DAHL
COO France | AzurBio Pharma | Pharmaceutical | Exploitant status Activities
Nouvelles
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Internship opportunity to support our Chief Financial Officer 👇 We are looking for a motivated and rigorous intern to support the CFO in the day-to-day management of the company's financial and administrative operations. This internship is an ideal opportunity to gain practical, in-depth experience in the fields of accounting, management control, and corporate finance. You can apply here: https://lnkd.in/dmdsV5rn
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Happy International Women's Day 2025 🙏 At AzurBio Pharma, we are honored to exemplify this advancement with our 100% women-led leadership team 👇 Corinne Schmitz - Founder & CEO Marlene Schuppli Nollet - Chief Commercial Officer Nadia Boehringer - Chief Operating Officer - Europe Sophie DAHL - Chief Operating Officer - France To-Quynh Gandolphe - Chief Pharmaceutical Officer Our commitment to fostering diversity, equity, and inclusion remains unwavering, as we recognize these values as catalysts for innovation and excellence in our field. Today, we stand alongside women worldwide, proud of their achievements and advocating for continued support and recognition in all sectors.
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AzurBio Pharma is proud to join fellow industry leaders in signing this important call to action addressing the urgent need to improve access to treatments for rare diseases in France. 🌍 With over 3 million patients affected, France has built a robust ecosystem in rare diseases. However, persistent challenges remain in securing sustainable access to orphan drugs. ✅ We fully support the 2 proposed measures: reinforcing innovation presumption in early access and adopting new criteria for reimbursement evaluations that reflect the unique realities of rare diseases. Accelerating patient access to innovation in France is our mission, enabling innovative companies to get to them as soon as possible. https://lnkd.in/eQh7JW7B
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AzurBio Pharma supports Rare Disease Day 🙏 We stand in solidarity with the 300 million individuals worldwide affected by over 6,000 identified rare diseases. These conditions, each affecting 1 in 2,000 people, collectively impact more lives than cancer and AIDS combined. Alarmingly, 70% of rare diseases begin in childhood, and 30% of children with a rare disease will not live to see their fifth birthday. Despite these challenges, 95% of rare diseases have no approved treatments. At AzurBio Pharma, our NorthStar is to streamline the process of bringing life-changing treatments to these patients. We encourage everyone to participate in the #RareDiseaseDay to raise awareness and show support. Together, we can make a difference and bring hope to those affected by rare diseases.
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We are hiring in France! As we support innovative biopharmaceutical companies in starting their operations in France, we are looking for new talents to join us in this adventure. At AzurBio Pharma, our mission is to ensure that cutting-edge therapies reach those in need as quickly and efficiently as possible. So if you’re excited about shaping the future of the pharmaceutical industry and enabling patient access to innovation, we invite you to explore our current job opportunities and discover how you can contribute to our mission. 👉 Apply for this position here: https://lnkd.in/dXDrUqDd
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We are pleased to introduce To-Quynh Gandolphe our Chief Pharmaceutical Officer, Pharmacien Responsable. Her 25+ year experience, gained in both the pharmaceutical industry and institutional settings (French Medicines Agency), ensures that our clients benefit from unparalleled insights into the European and French regulatory landscapes. Key Expertise Areas 👉 Quality Assurance "Exploitant" operations, with deep knowledge of French-specific requirements. 👉 Regulatory strategy. 👉 Advertising control. 👉 Clinical trials submissions and marketing authorizations procedures. 👉 Project management across regulatory and quality domains. Her 360° vision of pharmaceutical and regulatory affairs is a game-changer for clients navigating the European and French markets. With her ability to streamline complex quality and regulatory challenges, AzurBio Pharma provides a robust foundation for ensuring compliance, minimizing risks, and accelerating market entry—all while maintaining a patient-centric focus.
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How we are fast-tracking French market entry by up to 18 months for pharma companies 👇 This chart from IQVIA highlights a critical observation: while the U.S. leads in bringing new medicines to market quickly, France faces longer delays (~18 months) post-approval compared to other regions. What happens after approval? While price negotiations are ongoing, companies must also be prepared to launch at the right time. For France, this means, building an "Exploitant" structure, a complex and time-consuming process that can delay commercialization. This is exactly where 1 of our unique solutions makes a difference - an unmatched offering in today's market: simply acquire your Exploitant structure directly from us! Our innovative approach not only accelerates market entry for companies in France by up to 18 months but also minimizes risks and eliminates the need for early local recruitment. This ensures a faster, safer, and more efficient path to full commercialization. At AzurBio Pharma, we aim to transform pharmaceutical companies' challenges into opportunities. Let's work together to ensure no patient in France waits longer than necessary for the care they deserve. Source: IQVIA
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🎄 Happy Holidays from AzurBio Pharma! 🤶 As we close the year, we wish all our followers, customers, partners, and the pharma community a joyful Christmas and a fantastic New Year! 🎁 Rather than a traditional holiday visual, we’ve decided to share data that highlights how Europe remains a global hub for innovation, collaboration, and growth in the pharmaceutical sector. At AzurBio, we’re proud to support global biotechs in navigating this vibrant market, bringing life-changing treatments to patients across Europe. As we look to 2025, we will continue to push boundaries and accelerate access to innovation for European patients. 🎅 Warm wishes, The AzurBio Pharma Team
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Why setting up in France feels like climbing a mountain? ⛰️ Let’s be honest, setting up operations in France is no walk in the park for biopharmaceutical companies. Complex regulations, endless paperwork, and navigating the pharmaceutical landscape can make it feel more like an obstacle course than an opportunity. Burden examples of setting up your commercial affiliate in FR 👇 📜 Exploitant license: mandatory authorization by ANSM (French Health Authority). 🌍 Unique French local rules: a true "exception française" in regulation ⏳ Time-consuming process: 15–18 months to obtain the Exploitant License 🏢 Office setup: physical premises required from the onset 👥 Early local recruitment: critical roles like Chief Pharmaceutical Officer needed right from the start 🔄 Focus shifted: key teams diverted from other market launches to handle French setup But here’s the good news: it doesn’t have to be this way. At AzurBio Pharma, we turn what feels like a headache into a smooth, streamlined process. Imagine you can now buy a fully ANSM-authorized Exploitant structure from AzurBio Pharma, ready to operate so that you can launch your first product in France without delay! Why fight the mountain when you can have a guide? Let us help you make France your next success story! 🚀
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