Meet our team in January 2025! Scendea's Business Development team are excited to be back on the road and travelling to the US and Middle East this January. - Are you looking for support with your 2025 regulatory strategy? Get ahead and book a meeting now by searching 'Scendea' on the event partnering platforms, or get in touch www.scendea.com/contact - #DrugDevelopment #Partnering #RegulatoryAffairs #BiotechEvents
Scendea
Pharmaceutical Manufacturing
Bishop’s Stortford, England 7,243 followers
Scendea is a leading product development & regulatory consulting practice serving the pharmaceutical & biotech industry.
About us
Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. A combination of scientific excellence, industry experience, and a collaborative approach enables us to deliver high-quality innovative solutions, aligned with jurisdiction-specific regulatory requirements, which allow our clients to succeed. Our award-winning international team offers strategic and operational support in the fields of non-clinical, CMC, clinical, and regulatory, which guide products efficiently from early development to marketing approval. Scendea is proud to have received the prestigious King’s Award for Enterprise: International Trade 2024.
- Website
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http://www.Scendea.com
External link for Scendea
- Industry
- Pharmaceutical Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Bishop’s Stortford, England
- Type
- Privately Held
Locations
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Primary
20 The Causeway
Bishop’s Stortford, England CM23 2EJ, GB
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De Cuserstraat 93
Amsterdam, 1081 CN, NL
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4079 Governor Drive #5082
San Diego, CA 92122, US
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52 McDougall St
Corporate House, Level 2
Milton, Queensland 4064, AU
Employees at Scendea
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Mike Mulcahy
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John Cronin
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Patrizia Nestby, PhD MSc (Regulatory Affairs)
Regulatory Affairs Consultant, Director and Founder at Pioneer Regulatory Limited
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Dmitry Zamoryakhin, M.D., MBA, MFPM
Oncology & Rare Diseases R&D Leader | Ex Daiichi Sankyo, Oxford Biomedica, Grünenthal | Available For New Projects
Updates
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Are you based in Munich, Germany? Don't miss the chance to meet our Regional Business Development Manager, Wouter Stoffels, and discuss your 2025 regulatory strategy needs. Book a meeting now: www.scendea.com/contact - Scendea are proud to provide strategic and operational support in the fields of non-clinical, CMC, clinical and regulatory from early development to marketing approval. Explore Scendea's services and discover how we can support your medicinal product development: https://lnkd.in/gwDAaZFf - #regulatorysupport #drugdevelopment
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Scendea are delighted to share our 2024 Regulatory Intelligence Round-Up, highlighting key updates, milestones and deadlines from the FDA, European Medicines Agency, Medicines and Healthcare products Regulatory Agency & European Commission in 2024... https://lnkd.in/gWd3-KZp - Are you developing a medicinal product? Book an exploratory call with our experts to discover how Scendea can support your global agency interactions in 2025: www.scendea.com/contact - #regulatoryintelligence #drugdevelopment #regulatoryaffairs
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Are you attending BIO Partnering @ JPM Week? Scendea are delighted to be sponsoring and attending the event this coming January. Meet with our Director, Paul Cronin and discover how we can support your regulatory journey from concept to market. - Search 'Scendea' in the partnering platform https://lnkd.in/gavST-kq or get in touch now to book a meeting www.scendea.com/contact - #drugdevelopment #regulatoryaffairs #BIOJPM #collaboration #biotechevents
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The European Medicines Agency has updated its page on the new fee regulation (from 1st January 2025). The update includes the addition of a notification in preparation for the New Fee Regulation and new prepayment system for certificates of medicinal products. - For support with your product development, regulatory strategy and EMA interactions, get in touch www.scendea.com/contact - #EMA #drugdevelopment #regulatorysuppor
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Are you developing a Generic Inhalation Drug Product? Our whitepaper "Regulatory Pathway for Generic Inhalation Drug Products" written by Principal Consultant, Dr Justine Ramsden, is now available to read and download in full - https://lnkd.in/e4mkDQQi - The whitepaper explores the regulatory challenges, development complexities, and approval pathways for generic inhalation drug products, providing you with essential guidance to navigate this intricate landscape. - Meet our team of experts and discover how Scendea can support your 2025 development journey: www.scendea.com/about - #regulatorysupport #drugdevelopmet #whitepaper #inhalation
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The Medicines and Healthcare products Regulatory Agency has updated its guidance for applying for a license to market a medicine in the UK. The guidance provides an overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees. - To discuss this guidance with a member of our award-winning team, get in touch www.scendea.com/contact - #MHRA #guidanceupdate #regulatoryaffairs
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Scendea is excited to be back in San Francisco and attending Biotech Showcase! - Are you looking for expert regulatory guidance when developing your therapeutic or medicinal product? Scendea has extensive experience working with global regulators to bring a range of products to market. Secure a meeting now with our Chief Business Officer, Mike Mulcahy www.scendea.com/contact - #BiotechShowcase #drugdevelopment #regulatorystrategy