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Welcome to DLRC

Your Trusted Regulatory Partner at DDL 2024

We’re excited to continue the conversation and explore how we can support your inhalation therapy development needs. Whether you’re looking for expert regulatory guidance, strategic advice, or end-to-end solutions, DLRC is here to help you navigate the complex regulatory landscape of the life sciences industry. We are the strategic partner of choice, providing guidance to maximise your company and products.

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Dr Ian Ashurst
FRPharmS, MSc Principal Regulatory Consultant

Ian is a Principal Regulatory Consultant at DLRC. He is a Fellow of the Royal Pharmaceutical Society with a PhD in Pharmaceutics. Ian has worked in pharmaceutical development for 17 years, CMC technical leadership for 14 years, as a MHRA quality assessor for three years and for 6 years at DLRC. He has developed and assessed many inhaled products. His experience as a medicine developer, regulator and consultant, gives him a unique perspective and can develop successful strategies for clients. Ian worked on the last propellant transition from CFC to HFA propellants and is now helping DLRC's clients with their inhaled products.

Catherine Flynn
BSc Principal Regulatory Consultant

Catherine is a Principal Regulatory Consultant at DLRC, specialising in Chemistry, Manufacturing and Controls (CMC). Catherine has a B.Sc. in Chemistry and worked in radiosynthesis and analytical development before moving into Regulatory Affairs in the generics field 20 years ago, where she had her first taste of inhaled drug product registration. Catherine works with a range of clients at DLRC, advising on regulatory and CMC development strategy, authoring submissions and managing health authority interactions. She covers small molecules, biologics, ATMP, drug-device combinations and others across the product lifecycle. She has supported several inhaled product developments and brings a broad oversight of CMC regulatory and cGMP requirements.

Claire Meadowcroft
Chief Business Officer

Claire’s role involves shaping the company's commercial strategy and leading the business development team. Claire has many years of Industry experience and a track record of success building teams that are laser-focused on delivering for clients and creating lasting value in partnerships. Having worked with GSK and AstraZeneca and global and niche CROs, she is well-placed to support DLRC's new clients in their journey to navigate the increasing complexities of the regulatory landscape successfully. Claire obtained a bachelor’s in nursing and began her pharmaceutical career in clinical project management. She then studied for an MPhil in translational medicine & therapeutics at the University of Cambridge.

 

Who we are

DLRC is an award-winning consultancy team of more than 80 highly qualified, experienced regulatory professionals operating from our offices in the UK, Germany, and US. With a deep commitment to excellence, we are dedicated to helping clients navigate the complex regulatory landscape of the life science industry.

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Ready to take the next step in your product’s regulatory journey? Whether you need expert guidance, a comprehensive regulatory strategy, or a partner for end-to-end regulatory outsourcing, DLRC is here for you.

Whitepaper

In partnership with Koura

Regulatory Landscape for Transition to Low Global Warming Potential (LGWP) Propellants for Pressurised Metered Dose Inhalers (pMDIs)

As the global focus on climate change intensifies, the pharmaceutical industry must transition to more sustainable practices. This whitepaper summarises the regulatory requirements for transitioning to low global warming potential (LGWP) propellants in pressurised metered dose inhalers (pMDIs).

The paper focuses on European regulations and covers the background of the transition, including a brief look at the history of the previous transition from CFC propellants and the rationale for the current move. The regulatory requirements for quality, nonclinical, and clinical data are covered in detail, followed by an update on development status of two new propellants that will be key to the successful implementation in the next generation of pMDIs.

Read the whitepaper
Regulatory landscape for transition to low global warming potential (LGWP) propellants for pressurised metered dose inhalers (pMDIs) cover

Why Choose DLRC?

DLRC is a trusted partner for companies developing inhalation products. With a team of over 80 regulatory affairs professionals, we have successfully supported more than 130 companies of all sizes, from global pharma leaders to emerging start-ups. Here’s why we’re the right choice for your regulatory needs:

Global Expertise

Our offices in the UK, Germany, and the US allow us to offer expertise and regulatory solutions across multiple jurisdictions.

End-to-end Support

From early-phase development to post-licensing activities, we offer a full range of regulatory services for both medicinal products and medical devices.

Tailored Solutions

We create bespoke strategies that fit your product’s needs, timelines, and commercial objectives.

Proven Success

We have an extensive track record of guiding clients through complex regulatory challenges and achieving successful product approvals.

Discover how DLRC can maximise your company and products

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