Scendea

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

[Scendea @scendea]

The FDA has issued final guidance entitled Potency Assurance for Cellular and Gene Therapy Products.
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Developing a cellular or gene therapy product? Speak to our experts: https://t.co/7trYfVIdHC
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#CellularTherapy #GeneTherapy #FDAGuidance #RiskBasedStrategy #ProductLifecycle

[Scendea @scendea]

The MHRA and HRA have published findings from a six-month pilot evaluating Inclusion and Diversity Plans submitted alongside REC applications.
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Talk to our experts about evolving UK expectations impacting your clinical development programme: https://t.co/7trYfVIdHC

[Scendea @scendea]

London Life Sciences is just around the corner!
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Get in touch via https://t.co/7trYfVIdHC or search “Scendea” on the BioPartnering or LSX Investival partnering platforms to secure a meeting.
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#LondonLifeSciencesWeek #DrugDevelopment #Biotech #Pharma #CMC #RegulatoryStrategy

[Scendea @scendea]

BioLabs University of Toronto event "Drug Development Regulatory Pathways across the Globe" on November 19th at BioLabs University of Toronto.

[Scendea @scendea]

The FDA has announced the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program designed to accelerate medical innovation and deliver breakthrough treatments.
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Get in touch today to speak to our experts: https://t.co/7trYfVIdHC

[Scendea @scendea]

Would you know when to approach the FDA or EMA, before a critical development decision becomes expensive to change?
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🎥 Watch our recent webinar - Strategic FDA & EMA Interactions: Practical Approaches to De-Risk Development: https://t.co/CqpgKQ0ssR

[Scendea @scendea]

Is your team adequately prepared to meet GxP expectations?
Book a call with Scendea’s Compliance experts to learn more: https://t.co/7trYfVIdHC
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#GxPTraining #PharmaCompliance #RegulatoryStandards #QualityAssurance #ClinicalResearchTraining

[Scendea @scendea]

The FDA has released a draft guidance designed for applicants developing individualized gene editing (GE) products.
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Speak to Scendea’s experts about how we can support your regulatory strategy and BLA submission. Book at meeting: https://t.co/7trYfVIdHC

[Scendea @scendea]

Scendea is hiring!
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If you think you could be the perfect fit, explore the full job descriptions and apply today: https://t.co/16KCV95zgO
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#CareerOpportunities #QualityAndCompliance #SeniorConsultant #GMPJobs #GCPJobs #CMCRoles #CareerOpportunities

[Scendea @scendea]

There’s still time to arrange a meeting with Scendea at BIO-Europe 2026. Search for "Scendea" on the BIO-Europe partnering platform https://t.co/UHnwA5oJ2i or get in touch directly: https://t.co/7trYfVIdHC
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#BIOEurope #Biotech #Pharma #DrugDevelopment #RegulatoryAffairs

[Scendea @scendea]

Planning to be in London 16-19 November for London Life Sciences Week? Our meeting availability is filling fast, so get in touch directly at https://t.co/7trYfVIdHC to book a meeting.
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#LondonLifeSciencesWeek #LifeSciences #DrugDevelopment #Biotech #Pharma

[Scendea @scendea]

The EMA has launched an 18-month pilot for a revised pre-submission interactions model for initial marketing authorisation applications.
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Is an MAA on your development roadmap? Speak to our regulatory experts today: https://t.co/7trYfVIdHC

[Scendea @scendea]

If you’re based in Australia and would like to discuss your development strategy, upcoming milestones or regulatory challenges, take the opportunity to arrange a meeting with Daniel in person this November/December: https://t.co/7trYfVIdHC
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#DrugDevelopment #Biotech #Pharma

[Scendea @scendea]

Thank you to the Society of Physician Entrepreneurs (SoPE) for hosting a fantastic discussion on regulatory strategy and drug development.
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If you missed hearing from Scendea's experts, watch the webinar recording here: https://t.co/CqpgKQ0ssR

[Scendea @scendea]

The TGA has published the Therapeutic Goods Approval 2026, establishing the approved application forms for new, annual update and significant update submissions relating to Technical Master Files (TMFs) and Type II Plasma Master Files.
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Contact us at: https://t.co/7trYfVIdHC

[Scendea @scendea]

Scendea’s Compliance Division work alongside your team to custom build and strength your QMS to ensure it is compliant, practical, scalable and aligned with your day-to-day operations. Book a complimentary call with our Compliance experts, today: https://t.co/7trYfVIdHC

[Scendea @scendea]

Did you miss Scendea at Cell and Gene Therapy Meeting on the Mesa in Phoenix earlier this month?
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Book a 30-minute virtual consultation to discover how Scendea can help accelerate your gene therapy development journey: https://t.co/7trYfVIdHC

[Scendea @scendea]

BIO-Europe is coming up, and we’re looking forward to connecting with the global life sciences community in Cologne.
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Search "Scendea" on the partnering platform to arrange a meeting with our Director, Paul or contact us at: https://t.co/7trYfVIdHC

[Scendea @scendea]

The FDA has finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines.
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Speak to Scendea’s experts to explore how our CMC and regulatory expertise can support your program - https://t.co/7trYfVIdHC

[Scendea @scendea]

Thank you to everyone who took the time to connect and explore new partnerships with us at AusBiotech 2026 this week!
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If we didn't get a chance to catch up in person, get in touch here: https://t.co/7trYfVIdHC
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#AusBiotech #Biotech #Pharma #DrugDevelopment #RegulatoryAffairs