The @EMA_News has updated its pre-authorisation guidance on the 27/06/25, specifically revising the section on eligibility request submission dates for the centralised procedure. -.For support navigating #EMA guidance, get in touch: -.#regulatorysupport

Meet Scendea in Melbourne, Australia! Dr Babaji Yadav, is excited to be attending the Bio Connections event, hosted by Informa Connect on the 28th July!.-.Get in touch to secure a meeting: -.#BIOconections #drugdevelopment #regulatoryaffairs #biotechevents

On 30 June 2025, the MHRA updated its guidance on the legal bases for marketing authorisation applications in the United Kingdom. -.Do you require support with your MAA? Discover how our experts can assist: -.#marketingauthorisation

We are delighted to announce the release of our latest whitepaper, "Breakthrough Therapeutic Cancer Vaccines: Overcoming Challenges and Unlocking the Future of Immunotherapy", authored by Dr Babaji Yadav: -.#TherapeuticCancerVaccines

Yesterday, Scendea had the pleasure of attending the BIA Summer Garden Party in London, hosted by the OneNucleus group. -.Did you miss Scendea yesterday? Get in touch now and book an introductory call with the team: -.#drugdevelopment #regulatoryactivity

We are thrilled to announce Dr Kurt Gunter has joined the Scendea team as Principal Medical Consultant. -.Discover our full team of global experts: -.#LifeAtScendea #drugdevelopment #regulatoryaffairs #newstarter

Read and download our whitepaper, "Development & Regulatory Activities to De-risk & Support Your Fundraising Strategy". -.Read and download the whitepaper today: -.#DesriskInvestment #TorontoStockExchange #CanadianInvestment

Did you miss the latest guidance update from the FDA? Discover our article on the Commissioner's National Priority Voucher Program and discover how the Scendea team can help you navigate the new CNPV program: -.#CommissionerNationalPriorityVoucherProgram

The ICH has released the draft E20 guideline on “Adaptive Designs for Confirmatory Clinical Trials” marking the commencement of the Step 3 public consultation phase. For support navigating this guidance, speak to a member of our team: #guidanceupdage

We are thrilled to announce that Becky Murphy has been promoted to Marketing Director at Scendea. Discover Scendea's full team of experts or explore our open roles and register your interest today -.#lifeatscendea

Do you have a good working knowledge of the therapeutic product development process from early development to market approval? You could be the perfect fit. View the full job specifications and apply today: -.#businessdevelopmentroles #hiring

The @EMA_News has updated its pre-authorisation guidance. The update provides the latest calendar of submission deadlines for applicants seeking eligibility for the centralised procedure. -.To discuss this guidance, get in touch: -.#EMAguidanceupdate

Wishing all our friends, colleagues, clients, and followers in the US a joyful and celebratory 4th of July!.-.#4thJuly

We are delighted to announce that Dr Maria Beatrice Panico has been promoted to Deputy Chief Medical Officer & Principal Medical Consultant at Scendea. -.Join our global team of experts -.#LifeatScendea #drugdevelopment #ChiefMedicalOfficer

The @US_FDA has released the draft guidance on stability testing of drug substances. -.For support navigating US agency interactions, and for expert regulatory guidance, get in touch to speak with a member of the team: -.#drugdevelopment #drugsubstances

We are delighted to announce that Dr Krassimira Ourumova has been promoted to Chief Medical Officer here at Scendea. Discover Scendea's full team of experts or explore our open roles and register your interest today #lifeatscendea

Today, Scendea's Chief of Staff, Kat Cash, and Head of CMC, James Parsley, are attending One Nucleus' ON Helix conference. -.If you're attending #ONHelix, be sure to connect with the team. Alternatively, get in touch to book a last-minute meeting!

On the 17th June, the FDA announced its #CommissionersNationalPriorityVoucherProgram (CNPV) to enhance the health interests of Americans. -.Discover the full guidance and what we know so far in our latest article: -.#FDA #guidanceupdate #regulatoryaffairs

We are thrilled to announce that Caroline Keane has been promoted to Head of Clinical and Principal Consultant here at Scendea!.-.Discover Scendea's full team of experts and explore our open roles and register your interest today

Scendea is delighted to be attending the BIA Summer Garden Party in London next week!.-.Are you looking for regulatory support? Meet with Charles and discuss how Scendea can support your development journey: -.#drugdevelopment #biotechevents