DLRC Regulatory Consultancy

Last week, we had the honour of being officially presented with our King’s Award for Enterprise 2024! Earlier this year, DLRC was proudly recognised in the International Trade category of this prestigious award. To mark the occasion, team members from our UK office gathered to welcome Lord Lieutenant of Hertfordshire Robert Voss CBE CStJ, the official representative of His Majesty The King for the county of Hertfordshire, Deputy Lieutenant Dawid Konotey-Ahulu LLB, and High Sheriff of Hertfordshire Annie Brewster. During the ceremony, Lord Lieutenant Robert Voss highlighted the rigorous nature of the King’s Awards application process, explaining that: 🔵 Out of 6 million UK businesses, around 4,000 companies applied for the King’s Awards in 2024 🔵 Ultimately, just 252 companies were awarded a King’s Award for Enterprise in 2024, underscoring the immense achievement this represents After addressing the team and officially presenting the award, Lord Lieutenant Robert Voss joined us in cutting the celebratory cake with Annie Brewster’s sword, and we all enjoyed a piece together to mark the occasion. We extend our heartfelt thanks to Lord Lieutenant Robert Voss, Deputy Lieutenant Dawid Konotey-Ahulu, High Sheriff Annie Brewster, and all our guests for joining us. Here’s to continuing to make an international impact! #KingsAwardForEnterprise #BusinessExcellence #InternationalTrade #RegulatoryAffairs #Pharma

As we reflect on 2024, we're reminded of why our work matters - every regulatory milestone we help achieve brings life-changing treatments closer to patients who need them most. From supporting innovative #biotech start-ups through VITAL – A BARDA BAN Hub Accelerator and Discovery Park's Discovery Spark program, to raising nearly £10,000 for vital causes, to inspiring the next generation of #STEM leaders with local schools and Mission 44 - each initiative reflects our vision of making healthcare more accessible worldwide. This year also marked a significant milestone with our first Sustainable Impact Report, demonstrating our dedication to responsible business practices that support both people and the planet. None of this would be possible without the expertise of our exceptional team and our clients' trust in us to navigate complex #regulatory pathways. Together, we're not just meeting regulatory requirements - we're accelerating the development of treatments that transform lives. From all of us at DLRC, thank you. We wish you a joyful holiday season and a New Year filled with prosperity, good health, and exciting opportunities. Here's to continuing our mission of advancing global #healthcare in 2025! Read our full 2024 sustainability, education & community wrap-up here: https://lnkd.in/e_4dCj-6 #RegulatoryAffairs #GlobalHealth #LifeSciences #PatientAccess

DLRC is proud to announce the release of our first-ever Sustainable Impact Report!    While we’re not yet required to report on #ESG (Environmental, Social, and Governance) matters, we believe in leading the way.    By proactively embracing #sustainability, we’re ensuring that we can continue to deliver high-quality, compliant regulatory services—no matter how the landscape evolves.    This report highlights our 2023 achievements and outlines ambitious goals for 2024, all of which aim to positively impact our planet, team, clients, and community.    We hope that sharing our progress inspires others to take meaningful action on climate and societal issues. Together, we can shape a more sustainable future.     Find out how we have been making a difference: https://lnkd.in/e6bqyKDm   #SustainableBusiness #ImpactReport #Pharma #RegulatoryAffairs

It's Official – in just under 2 Months, Stuart Hunter, Business Development Lead, will be in #TheBigApple attending the Biotechnology Innovation Organization CEO & Investor Conference 2025, with partnering now open! The BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded, late-stage private biotech companies. The conference provides a yearly forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to shape the future investment landscape of the biotech industry. This years event, hosted in New York City, will feature a number of issue-oriented plenary sessions and fireside chats on hot-topics such as obesity medications, the use of AI in drug development, and policy outlook in the wake of the recent US election. In addition, there will be company presentations focussing on the latest innovations in biotech, partnering meetings, and plenty of networking opportunities! If you will also be attending, don’t miss the chance to meet with Stuart to discuss how our experts at DLRC can support your biotech company and products, from early stage development through to product approval and beyond. Request a meeting by searching for DLRC in the BIO Partnering™ system, or email us at hello@dlrcgroup.com #BIOCEO25 #InnovationInBioTech #PharmaEvents #RegulatoryAffairs #NYC

Less than one month to go! Claire Meadowcroft, Chief Business Officer, and Stuart Hunter, Business Development Lead, are very excited to be attending BIO@JPM Week in January, hosted in San Francisco, with BIO Partnering @JPM week open! This annual event is one of the largest and most influential gatherings in the healthcare and life sciences industry, bringing together #BioTech and pharmaceutical leaders for the annual Healthcare Conference. In addition to the main event, #JPMWeek features hundreds of networking events, conferences, and presentations, as well as those all-important one-to-one meetings! If you will also be attending, don’t miss the chance to discuss with Claire and Stuart how our experts at DLRC can support your company and products. Request a meeting by searching for DLRC in the BIO One-on-One Partnering system, or email us at hello@dlrcgroup.com #PharmaEvents #RegulatoryAffairs #HealthcareAndLifeSciences #SanFrancisco

Last week, Greg Dombal, President of DLRC’s US office, participated in the inaugural meeting of Accelerator Hub, VITAL – A BARDA BAN Hub!   VITAL supports the development and acceleration of next-generation #therapeutic and #vaccine platforms and technologies.   Greg delivered an interactive seminar on the regulatory process in the US and strategies for engaging the #FDA to the ten pioneering companies taking part in #VITAL.   The companies had specific questions about #INTERACT Meetings, special designations, what questions to ask the FDA and when, and how to bring external #regulatory expertise into their teams.    The 90-minute discussion touched on how the FDA works with sponsors and highlighted DLRC's experiences in collaborative work with the agency and its clients. Greg will continue to support VITAL as a strategic regulatory sounding board to help innovators align their regulatory strategies with their business objectives. Are you an anti-infective or anti-viral company ready to bring your therapeutic or vaccine innovations to market?   Email us at hello@dlrcgroup.com to discover how DLRC’s strategic expertise can maximise your impact. #RegulatoryAffairs #RegulatoryStrategy #Biotech #Pharma

It’s now less than a month until Stuart Hunter, Business Development Lead, will be in San Francisco for RESI JPM 2025, with partnering for RESI open now! RESI is an annual conference held concurrently with JPM week, which Stuart will also be attending with Claire Meadowcroft, Chief Business Officer. Stuart will be attending the in-person event only, held on January 14th. This day will include partnering meetings, as well as a variety of panels and workshops on topics including early stage therapeutics, women’s health, medical devices, oncology investment, and paediatrics. The event typically draws over a thousand attendees including investors, innovators, and industry experts, many of whom are also in the city attending #JPMWeek. If you will also be in San Francisco and would like to discuss with Stuart how our experts at DLRC can support your company and products, search for DLRC in the RESI partnering system, or email us at hello@dlrcgroup.com #PharmaEvents #RegulatoryAffairs #RESIJPM2025 #BioTech #SanFrancisco

It’s the final day of #DDL2024, and our experts Claire Meadowcroft, Chief Business Officer, Ian Ashurst, Principal Regulatory Consultant, and Catherine Flynn, Principal Regulatory Consultant, are excited to see what the last day has in store for them! Yesterday, Ian and Catherine attended Session 4, ‘Advances in Nasal Drug Delivery’, with some of their key take-aways from this session including; 🔵 An epinephrine nasal inhaler was approved in the US which is an important alternative to the auto-injectors. 🔵 There are many benefits to nasal drug delivery such as non-invasive, rapid onset of action, easy administration of the dose and bypass of 1st pass metabolism. 🔵 Nose to brain pathways were highlighted and reviewed and it was clear that different options are available to the developer. 🔵 Vaccines are an important target as 27% of deaths world-wide are due to communicable diseases. Current work shows promising results including good stability with dry powder formulations. 🔵 Untranslated administration is growing at about 6-7% per year driven by a patient preference for self-administration of doses. 🔵 Choice of species for non-clinical modelling of nasal drug delivery can depend on several elements including compound type, biological target, formulation and intended volume. 🔵  Delivery of drugs through the nasal membranes can be complicated by low volumes, poor retention, poor mucoadhesion and efficient mucociliary clearance. 🔵 Effective droplet formation in the delivery nasal sprays depends on adequate shear rate and velocity during atomisation. Devices currently in development offer an optimised fluid path that is able to cope with more viscous solutions and may be further fine-tuned. After this, the team got glammed up Christmas style – Santa hats and all - ready to attend the DDL 2024 Gala Dinner, held at the National Museum of Scotland. The event featured a delicious meal, great networking, and Claire even got to take a selfie with Dolly the sheep! If you are also attending DDL 2024 today, don’t forget to check out Stand 107 on Floor -2 for more conference talk, and to discuss with Claire, Ian and Catherine how our experts at DLRC can support your pulmonary and nasal drug delivery products! Alternatively, you can also email us at hello@dlrcgroup.com #PharmaEvents #RegulatoryAffairs #NasalDrugDelivery #NationalMuseumofScotland #GalaDinner

DLRC experts Catherine Flynn and Ian Ashurst are having an interesting time at #DDL2024, particularly enjoying Session 1 of DDL on the transition to new low global warming potential (#LGWP) propellants in pressurised metered dose inhalers (#pMDIs). This topic is of special interest to DLRC, who have written a white paper co-authored with Koura on the regulatory requirements for the transition, which you can find here: https://lnkd.in/epfGVxHy During the session, Maureen Hardwick, legal counsel and secretariat of the IPAC organisation gave an excellent presentation covering the multiplicity of regulations governing the transition and focused on how a multi-stakeholder approach was key to a successful transition - key stakeholder groups need to work together to ensure patients are not disadvantaged. Sara Panigone, a device expert from Chiesi, then examined three key questions which need to be addressed during the transition: 🔵 When will the new propellants be available? 🔵 How do we develop them into drug products? And 🔵 What is the view of the regulators? She then went on to describe how a beclometasone / formoterol / glycopyrridonium triple combination product has been developed in HFA-152a and has been shown to be therapeutically equivalent to its HFA-134a equivalent. It is fascinating to see that the first new drug product that may be approved with a novel LGWP propellant could be a triple combination product! Finally, John Bell, a pharmacologist from AstraZeneca, presented on the current solutions and future threats. It was highlighted that HFO-1234ze may be challenged by upcoming plans to restrict the use of PFAS (polyfluorinated alkylated substances). HFA-152a may also be challenged by the EU phaseout and AIM phase down regulations due to its higher global warming potential than HFO-1234ze, although it still has an order of magnitude reduced global warming potential than that of the HFAs. The session was concluded with a Q&A where a number of challenging ideations were raised, including the challenges of redeveloping all of the current pMDI portfolio – there is a long way to go. It was postulated that some products could be lost in the transition as some of the lower value products may not be redeveloped. The drive to greater sustainability is critical but it is also important to remember that a suitable range of therapeutics – that work – needs to be available, as the ‘greenest’ patient is a patient with well controlled disease. If you are also attending DDL 2024, don’t forget to check out Stand 107 on Floor -2 for more DDL insights, and to discuss with Claire, Ian and Catherine how our experts at DLRC can support your pulmonary and nasal drug delivery products! Alternatively, you can also email us at hello@dlrcgroup.com #DDL2024 #PharmaEvents #RegulatoryAffairs #MedicinesForInhalation

Our experts Claire Meadowcroft, Chief Business Officer, Ian Ashurst, Principal Regulatory Consultant, and Catherine Flynn, Principal Regulatory Consultant, had a busy first day at #DDL2024, and are looking forward to seeing what Day 2 has to offer! The DLRC stand has seen lots of interest, and Ian, Catherine and Claire were also able to check out some of the sessions on offer. Ian and Catherine particularly enjoyed Session 1, ‘Transition to New Propellants – Current Solution and Future Threat’, which focussed on the transition to new low global warming potential (#LGWP) propellants in pressurised metered dose inhalers (#pMDIs), a topic which DLRC has particular expertise in. If you are also attending DDL 2024 today, don’t miss the chance to say ‘Hi’ – head to Stand 107 on Floor -2 to discuss with our experts how DLRC can utilise its considerable experience in pulmonary and nasal drug delivery products to help your company and products. Alternatively, you can also email us at hello@dlrcgroup.com #DDL2024 #PharmaEvents #RegulatoryAffairs #MedicinesForInhalation