Scendea @scendea
Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Scendea.com Joined May 2020-
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The @MHRAgovuk has invited sponsors to join a pilot for Route B substantial modifications ahead of the new clinical trials regulations coming into force on the 28/04/26. - For expert regulatory guidance, get in touch today: scendea.com/contact - #clinicaltrialsupport
We are proud to share that Scendea and our talented team, Ian Waterson, Dr Asha Kattige and Ellie McNamee, are finalists in the TOPRA Awards for Regulatory Excellence 2025! - Discover how Scendea's award-winning team: scendea.com/about - #TOPRAawards2025
The ICH has announced the M14 Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise RWD for Safety Assessment of Medicines” has reached Step 4 of the ICH Process. - Discover the full guidance: scendea.com/contact
Are you attending AusBiotech this October? The partnering platform is now open. Book a meeting with Scendea and discover how we can support your global therapeutic or medicinal product development: scendea.com/contact - #partneringopportunity #drugdevelopmentsupport
We’re excited to share that our Director, Paul Cronin, will be travelling around the US over the next few months! - Paul's looking forward to collaborating in the United States. Get in touch now to secure a meeting! scendea.com/contact #drugdevelopment #partneringopportunity
Scendea are delighted to be attending Bio Europe Autumn! Book a meeting with our experts by searching 'Scendea' in the partnering platform, or get in touch today to secure an early meeting slot: scendea.com/contact - #drugdevelopment #regulatoryaffairs #BioEuropeAutumn
The @EMA_News has announced a public call for experts to join its Scientific Advisory Group on Immune and Inflammatory Diseases. - Discover how Scendea can support your product development and regulatory activities: scendea.com/contact - #drugdevelopment #regulatorysupport
If you didn’t get the chance to meet Ian and Al during the conference and would like to explore how Scendea can support your nonclinical and toxicology-related activities, get in touch to schedule a virtual meeting: scendea.com/contact
Book a meeting by searching 'Scendea' on the BioJapan partnering platform, or contact us directly at scendea.com/contact to explore how we can support your regulatory and product development goals. - #BioJapan #drugdevelopment #globalregulatorypartner
The EMA has updated its Pre-Authorisation guidance document to provide clearer information for applicants preparing MAAs under the centralised procedure. - #EMA
Are you attending Cell & Gene Meeting on The Mesa this October? Book a meeting by searching 'Scendea' in the partnering platform, or get in touch Scendea.com/Contact - #CellAndGene #BiotechConference #ATMP #MeetTheExperts
Could your rare disease therapeutic qualify for faster FDA approval? Read our new whitepaper: scendea.com/articles/fdas-…
Our team has availability for in-person meetings and can provide tailored advice to support your regulatory strategy and product development challenges. View our event schedule below and get in touch to arrange a meeting: scendea.com/contact - #MedicinalProducts
Join Scendea at EuroTox! Our Head of Non-Clinical & Principal Consultant, Ian Waterson, along with Business Development Consultant, Al Mills, are enjoying meaningful networking in Athens for #EUROTOX2025. - #Athens2025 #PharmaConference #ToxicologyExperts #NonClinicalResearch
The FDA has issued final guidance on the Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. - #Biosimilars #TherapeuticProteins #FDAGuidance #DrugDevelopment #Pharmaceuticals #QualityAssessment
We're delighted to announce that Billy Wong has joined the Scendea team as Finance Manager. Discover our full team of global experts: scendea.com/about - #LifeAtScendea #drugdevelopment #regulatoryaffairs #newstarter
Scendea are delighted to be attending BIOSPAIN 2025 this October! Search 'Scendea' in the partnering platform, informaconnect.com/biospain/pone/… or get in touch today to secure an early meeting slot: scendea.com/contact - #drugdevelopment #regulatoryaffairs #BIOSPAIN
We're delighted to announce that Emma Hawke has joined the Scendea team as Deputy Head of Product Development & Regulatory Consulting, Senior Consultant. Discover our full team of global experts: scendea.com/about - #LifeAtScendea #drugdevelopment #regulatoryaffairs
The EMA has published the submission deadlines and assessment timetable for PRIME eligibility requests for 2026. Do you require support with your PRIME submissions? Get in touch to speak to a member of our team Scendea.com/Contact - #EMAPRIME
Are you confident in your paediatric development strategy? Book an exploratory call with our expert team, today: Scendea.com/contact - #PaediatricDevelopment #RegulatoryAffairs #ComplianceStrategies #PediatricResearch #DrugDevelopment #ClinicalTrials #EURegulations
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