The FDA has finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines. - Speak to Scendea’s experts to explore how our CMC and regulatory expertise can support your program - scendea.com/contact

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

The FDA has released a new framework for Rare Disease Review that outlines the plan for a more consistent and fit-for-purpose approach to rare disease drug development. - Get in touch at: scendea.com/contact - #RareDisease #DrugDevelopment #FDAFramework #RegulatoryAffairs

Scendea's Director, Paul Cronin, and Head of CMC & Principal Consultant, Dr James Parsley, are available for in-person meetings from 16th to 19th November during LLSW. - Book directly at: scendea.com/contact - #LondonLifeSciencesWeek #BioPartnering #LSXInvestivalShowcase

The MHRA has published its Strategy 2030, outlining its vision for modernising regulation in response to advances in science, technology and healthcare. - Book a meeting: scendea.com/contact - #MHRA #RegulatoryExcellence #ProductDevelopment #HealthcareInnovation

Broadcasting live today! - Don’t miss the opportunity to join this expert lead webinar! Register: zoom.us/webinar/register/WN_… - #Webinar #PharmaceuticalIndustry #RegulatoryAffairs #FDA #EMA #DrugDevelopment #AgencyEngagement #PediatricResearch #PriorityReviewVoucher

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

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

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

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

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_…

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

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

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

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

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…

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

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

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

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.