DLRC Regulatory Consultancy

The August Edition of The Insight has arrived and is in higher demand than ever! The Insight has been delivered directly to our subscribers' inboxes, full to the brim with regulatory news that our experts have translated into one valuable, actionable and exclusive package. But you don't have to miss out if you missed the release! You can still receive The Insight and join our growing community of industry professionals for free on the DLRC website: https://lnkd.in/euvYrxzA 📥 We hope you enjoy the edition as much as we did putting it together. If there are topics we haven't covered but you want to see featured in The Insight, let us know in the comments and we'll see what we can do! 👇 #RegulatoryAffairs #RegulatoryNews #PharmaRegulation #RegulatoryUpdates

It's just one week until LSX World Congress USA 2024! Secure your slot to meet Greg Dombal, President of DLRC Inc., on September 11th—12th at this year's event, held at Hynes Convention Centre, just 15 minutes from our US office. To discuss how DLRC can support your company and products with Greg, search for DLRC in the partnering app and request a meeting at a time that works for you. #PharmaEvents #RegulatoryAffairs #LSXWorldCongressUSA LSX - partnering for Life Science eXecutives

#EMA recently issued revised (draft) guidance on the #pharmaceutical quality of inhalation and nasal #medicinal products.     Discover the key changes in the draft guidance in our recent article: https://lnkd.in/esuAiQDS   Our Inhaled #CMC consultants Ian Ashurst and Roy Pengilley, with over 60 years collective knowledge working in this area, will be able to help you understand the implications of this update for your company.    To discuss your requirements with Ian and Roy, email us at [email protected]    #InhalationProducts #NasalProducts #RegulatoryAffairs

This month Angela Bonich, Head of Business Development, is heading to #Malmö in Sweden for NLSDays 2024! If you are attending NLSDays, don't miss the chance to connect with Angela and discuss how DLRC can support your regulatory goals. Secure a meeting by searching for DLRC in the PartneringONE app, or email our team at [email protected] #PharmaEvents #NLSDays2024 #RegulatoryAffairs

In May, Women's Aid Federation of England delivered DLRC’s monthly Health and Wellbeing Talk on domestic abuse. Domestic abuse is a heavy topic, but it is a crucial conversation that needs to be addressed to raise awareness and provide support for those affected.   Our team were informed of statistics and some incidences of domestic abuse in the UK; it was also highlighted that employers can play a critical role in supporting those who experience domestic abuse. To this end, since May, we have written a Domestic Abuse Policy and joined the Employers' Initiative on Domestic Abuse (EIDA).   The Mission of the EIDA is: “to equip employers to support their employees affected by domestic abuse and to share best practices with other employers. We endeavour to bring about constructive change, leading to a society where survivors thrive and where domestic abuse is not tolerated.”   Through signing up to the EIDA charter DLRC has committed to: 1️⃣ Raising awareness among their employees of the many forms domestic abuse can take 2️⃣ Fostering a safe, supportive and open environment to allow domestic abuse to be effectively tackled in the workplace 3️⃣ Supporting employees who are affected by domestic abuse and those who report it by providing access to information and services 4️⃣ Providing education and support to help perpetrators of domestic abuse to stop 5️⃣ Sharing best practices with other employers   We are determined to provide excellent-quality employment and foster a positive wellbeing environment for all employees. Our commitment to the #EIDA principles supports essential aspects of DLRC’s values and our goal of being a supportive, responsible employer. #DomesticAbuseAwareness #WorkplaceWellbeing #EmployeeSupport

Partnering is open for Cell & Gene Meeting on the Mesa! We are pleased to announce that Greg Dombal, President of DLRC Inc., will attend this year's event in #Phoenix. DLRC supports #ATMP developers in managing the unique regulatory challenges these types of products encounter, from very early product development to post marketing maintenance.    With specialists in #CMC, #nonclinical and #clinical product development, as well as in-house medical writing and publishing groups, DLRC can provide strategic, tailored navigation of national and global #regulatory pathways to ensure these innovative products get to patients faster. To connect with Greg and discuss how DLRC can support you, search for DLRC in the partneringONE app. #PharmaEvents #CellandGene #DrugDevelopment Alliance for Regenerative Medicine

Discover the transformative potential of one-off, curative ATMPs! Unlike traditional treatments, ATMPs offer long-term benefits despite their high upfront costs.    With the EU and UK reshaping funding models, it's crucial to understand legislative changes, recent approvals, and reimbursement strategies. DLRC advises drug developers to prioritise Health Technology Assessments (#HTA) early, ensuring successful reimbursement strategies despite challenges like small patient populations or high costs. Our expertise in #PRIME and #ITF initiatives provides integrated solutions for #ATMP clients.    Europe's diverse national policies and healthcare infrastructures create disparities in patient access. Specialised administration requirements and high costs complicate market access, emphasising the need for tailored strategies. Innovative payment models—conditional reimbursement, pay-for-performance, and annuity-based payments—address cost and effectiveness uncertainties, streamlining market access and aligning payer-manufacturer incentives. Our latest article dives into how these changes impact HTAs and what they mean for your market access strategy. 👇 Navigating these complexities demands expert guidance. DLRC is here to help your ATMPs achieve regulatory success and optimal market access strategies. Contact us today at [email protected] to prepare for the future of healthcare innovation.    #HealthcareInnovation #RegulatoryStrategy #MarketAccess

Do you have a robust nonclinical regulatory strategy to ensure regulatory compliance? Connect with us today to leverage Sharon Robinson’s expertise and ensure you have the bespoke nonclinical regulatory support needed for your regulatory development program. To arrange a virtual meeting at a time that suits you, email our team of #nonclinical experts at [email protected] For more information on our award-winning #regulatory services, go to www.dlrcgroup.com #RegulatoryAffairs #RegulatoryStrategy #Pharma #DrugDevelopment

Are you aware of the current regulations on Environmental Risk Assessment for medicines in the European Union and the regulatory expectations for marketing authorisation applications? The revised #EMA Guideline on the ERA of Medicinal Products for Human Use was issued on 15 February 2024 and replaces the original 2006 guidance. The revised guideline is more comprehensive and provides more explicit direction on several topics. The updated requirements for ERA come into effect on 01 September 2024. Our recent blog covers the scope and legal basis for #ERA, general considerations and the step-wise procedure recommended for assessment. 👇 DLRC’s team of regulatory experts can advise on current regulations and support your regulatory filings. To discuss this topic with us, contact us at [email protected]. European Medicines Agency #EMA #EnvironmentalRiskAssessment #RegulatoryAffairs

Have you read the revised CTIS transparency rules but are unsure how they impact your patent filing strategy? In our latest whitepaper, authored by James Biddlecombe, Business Transformation & CTR Lead, and Karen Ng, Associate, European and UK Patent Attorney at J A Kemp, we explore patent filing considerations in light of the revised Clinical Trials Regulation transparency rules. 👇   Our partnership with J A Kemp, a leading firm of European patent, trade mark and design attorneys, enables us to provide you with a holistic view from both regulatory and legal expertise.   We feature what the new #CTIS transparency rules mean for publishing your data, provide #patent filing considerations, and highlight the importance of engaging and coordinating the legal and regulatory teams early on and throughout the life cycle of clinical trials to optimise patent filing opportunities.   If you would like assistance with your clinical trials, strategy or submission, contact our regulatory experts at [email protected] www.dlrcgroup.com #ClinicalTrials #RegulatoryAffairs #PatentStrategy #CTIStransparency