Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry.

Joined May 2020
BIO-Europe is just around the corner! - Scendea's Director Paul Cronin would be delighted to meet to discuss your development programme. Search "Scendea" on the partnering platform. - #BIOEurope #Biotech #Pharma #DrugDevelopment #RegulatoryAffairs
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Scendea is delighted to be attending LSX Investival Showcase Europe in London on Monday, 16 November. - Search "Scendea" to connect with our Director, Paul Cronin, through the partnering platform to book a meeting. - #LSXInvestival #DevelopmentProgramme #RegulatoryStrategy
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The EMA has updated its pre-authorisation procedural advice for users of the centralised procedure. - Arrange a meeting with Scendea's experts to help you develop a robust regulatory strategy: scendea.com/contact - #orphanmedicines #paediatricresearch #regulatorystrategy
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The EMA has released a page for PRIME: eligibility requests and outcomes and key eligibility request figures, removing it from the PRIME: priority medicines page. - Speak to our experts: scendea.com/contact - #EMAPRIME #RegulatoryStrategy #DrugDevelopment #Pharmaceuticals
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Scendea’s experts are joining the SoPE webinar "Strategic FDA & EMA Interactions: Practical Approaches to De-risk Development" on October 21 to discuss proactively engaging with the FDA and EMA to make informed development decisions. - Register today: zoom.us/webinar/register/WN_…
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The MHRA has joined international medicines regulators in endorsing a joint statement from the ICMRA that calls for the advancement and implementation of alternatives to animal testing throughout the lifecycle of human medicines. - Book a meeting: scendea.com/contact
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The EMA has updated submission deadlines for ATMP certifications under micro, small, and medium-sized enterprises. - Contact Scendea's experts today: scendea.com/contact - #ATMP #RegulatoryStrategy #EMAUpdates #MedicinalProducts #DevelopmentProgramme
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We're looking forward to attending AusBiotech 2026, Australia's largest life sciences conference, from 21-23 October. - To arrange a meeting with Scendea in advance, visit: scendea.com/contact - #AusBiotech #LifeSciences #Biotech #Pharma #DrugDevelopment #RegulatoryAffairs
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The EMA has announced that it will develop a regulatory roadmap on medicines for women’s health by the end of 2026... - Speak to Scendea's experts to ensure your development programme is prepared for the evolving regulatory landscape in women's health: scendea.com/contact
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Join Leanne West, Principal Consultant at Scendea for the UK Business Academy webinar "Accelerating Research and Development: The Competitive Advantage of Clinical Trials in Australia" on 20 Oct 2026. - Register here: business.gov.uk/business-aca…
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The FDA has issued a direct final rule updating its nonclinical testing regulations to clarify that appropriately validated non-animal methods may be used to generate safety data for drugs and biologics before human studies. - Get in touch: scendea.com/contact
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We look forward to connecting with biopharma companies from South Korea and APAC as KoNECT 2026 gets underway this week. - If you're attending KoNECT and would like to arrange a meeting, get in touch: scendea.com/contact - #KoNECT2026 #DrugDevelopment #Biotech #Pharma
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Today, Scendea joins the rest of the world in recognising World Mental Health Day, a day to raise awareness of mental health issues globally and to mobilise efforts in support of mental health. - #WorldMentalHealthDay
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Scendea is delighted to be sponsoring BIO Partnering @ London Life Sciences Week from 16-19 November. - Search "Scendea" on the partnering platform to book a meeting with our Director, Paul Cronin and Head of CMC & Principal Consultant, Dr James Parsley.
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MHRA updates its Stepwise 14-Day Assessment Programme for Phase 1 clinical trials. - Speak to Scendea's experts to discuss how these changes could impact your Phase 1 clinical development strategy: scendea.com/contact - #MHRA #ClinicalTrials #Phase1Trials #DrugDevelopment
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Will you be at BIO-Europe this November? Search for Scendea on the partnering platform to arrange a meeting, or get in touch directly: scendea.com/contact - #BIOEurope2026 #DrugDevelopment #RegulatoryStrategy #ClinicalDevelopment #CMC #Biotech #LifeSciences
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Day 2 at BioJapan and it's been a fantastic start! - If you're attending BioJapan and would still like to connect, we'd be pleased to arrange a meeting: scendea.com/contact - #BioJapan #DrugDevelopment #GlobalRegulatoryPartner #RegulatoryStrategy #LifeSciences
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Regulatory interactions can shape the trajectory of your development program, but are you getting the most value from each agency engagement? - Register for the webinar here: zoom.us/webinar/register/WN_… - #Webinar #RegulatoryAffairs #FDA #EMA #DrugDevelopment #AgencyEngagement
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A warm welcome to McKenna Rangel as she joins the Scendea team as an Associate Consultant. - Discover our full team of global experts: scendea.com/about - #Scendea #WelcomeToTheTeam #RegulatoryAffairs #DrugDevelopment #LifeAtScendea
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The ICH has published the final version of the "M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver". - Speak to our team: scendea.com/contact - #Bioequivalence #ICHGuideline #RegulatoryStrategy
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