Scendea

The FDA has announced the availability of the draft ICH E20 guidance in the Federal Register, outlining key principles for designing, conducting, analysing, and interpreting adaptive clinical trials intended to demonstrate efficacy and support regulatory decision-making. - For more information on this guidance, or to speak to a member of our expert team, get in touch: www.scendea.com/contact - #FDAguidanceupdate #drugdevelopment #regulatoryaffairs #clinicaltrialdesign

Did you miss Scendea at Cell and Gene Meeting on the Mesa last week in San Diego? Scendea's experts have extensive experience supporting the product development and regulatory activities for many cutting-edge Cell Therapy products. - Meet our expert team for a 30-minute virtual consultation, and discover how Scendea can support your 2025/26 development journey: www.scendea.com/contact - #celltherapy #cellandgene #drugdevelopment

Are you attending NY Metro & Builds BIO+'s 8th Annual Symposium for Life Science Innovation and Development? Book a meeting with Scendea's Head of Business Development, Meredith Manuel. - Why book a meeting with Scendea? Our expert-led sessions provide tailored guidance to help you navigate global regulatory requirements, whether you are seeking entry into US, EU, UK, or Australian markets, Scendea’s team can customise sessions to suit your needs. Get in touch: www.scendea.com/contact - #drugdevelopment #regulatoryaffairs #USbiotechevents

We are delighted to announce that Daniel Berg will be attending AusBiotech this month in Melbourne, Australia. Daniel is excited to meet with new and existing clients and would welcome the opportunity to connect during the event. Secure your meeting with Daniel by searching 'Scendea' in the AusBio partnering platform or get in touch at: www.Scendea.com/Contact - #LifeSciencesExpert #BiotechInnovation #PharmaGrowth #AusBiotech2025

Discover key Regulatory Intelligence updates released by the MHRA on October 1st 2025 and understand the impact when conducting a clinical trial prior to the 28th April 2026. https://lnkd.in/gyAKEJtn - For regulatory support when preparing for the implementation of new regulations and for expert guidance and support when conducting a clinical trial in the UK, get in touch: www.scendea.com/contact - #clinicaltrialsupport #medicinalproductapproval

Meet the authors from our latest Whitepaper: "FDA’s Rare Disease Evidence Principles (RDEP): What We Know So Far", Principal Consultant, Karen Sturgeon and Consultant, Nohman Mohammad. - The paper discusses the FDA's announcement of a new review process for rare diseases based on a molecule’s “plausible mechanism” which would allow the FDA to consider approval on a conditional basis. Discover how this impacts your drug development timelines in our latest whitepaper: https://lnkd.in/exMCnYU4 - #RDEP #FDAguidanceupdate #drugdevelopment

NLS Days 2025 is well underway, and our experts, Head of CMC & Principal Consultant, James Parsley, and Business Development Consultant, Al Mills, are excited for a busy few days! - Are you in need of EU regulatory support? James' expertise is in CMC biopharmaceuticals and has 20 years’ experience in the pharmaceutical industry with a broad regulatory background in terms of regulatory disciplines and therapeutic areas. Book a last-minute meeting with James and Al by getting in touch directly, or by searching 'Scendea' on the partnering platform: https://lnkd.in/emgxDEq7 - #drugdevelopment #regulatorysupport #Nordiclifescience

The FDA has introduced a new pilot program to expedite the review of abbreviated new drug applications (ANDAs) submitted by companies that conduct bioequivalence testing and manufacture their generic drug products domestically. - To discuss this guidance, and for expert regulatory support, get in touch: www.scendea.com/contact - #drugdevelopment #ANDA #genericdrugmanufacturing #FDA

The European Medicines Agency has published a draft reflection paper outlining how patient perspectives can be integrated into the regulatory evaluation of medicines. This guidance highlights the use of patient experience data, including patient-reported outcomes and patient preference studies, to inform benefit-risk assessments throughout the medicine lifecycle, from pre-authorisation to post-marketing. - For support navigating your 2025/26 drug development strategy, get in touch today: www.scendea.com/contact - #drugdevelopment #medicineregulation #regulatorystrategysupport

This week, Scendea's Regional Business Development Manager, Daniel Berg, had the pleasure of connecting with our strategic partners, CUES Consulting, and attending BioJapan in Yokohama, Japan! - Thank you to our friends at CUES for their warm welcome and hospitality! If you are seeking Japanese regulatory approval for your medicinal product, get in touch to discover how Scendea and CUES Consulting can assist with your product development and regulatory approval: www.scendea.com/contact - #drugdevelopment #regulatoryaffairs #BioJapan