Career progression is rarely linear, and there is no single path to leadership. In our latest blog, Sinéad McKeon discusses what drove her move from the lab bench to project management. She reflects on the capabilities...
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Mechanism of action in pediatric research
Discover how EMA’s proposed MoA-based PIP requirements mirror the US RACE for Children Act and how sponsors can prepare for pediatric regulatory changes.
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Managing risk for medical devices part 4
This blog looks into the logical basis for the use of comparisons in biological risk estimation. The same basic principle has been used for over 50 years. A comparative approach, presented as guidance in ISO 10993-18:2005, has now been transformed into a key element of ISO 10993-1:2025.
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Managing risk for medical devices part 3
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation.
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Managing risk for medical devices part 2
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation. In this edition we discuss ISO 14971: What it is and is not.
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Understanding FDA regulations for AI in SaMD
Despite an increase in AI-enabled medical devices receiving FDA approval there is no distinct regulatory route. Learn about FDA guidance on AI in SaMD.
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Strategies for successful Integrated Summary of Efficacy and Safety (ISS/ISE) submissions
Developing an integrated summary of safety and efficacy (ISS/ISE) can be complex. This blog outlines practical strategies to organise data, plan efficiently and ensure compliant, high-quality submissions.
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Customer advocacy: A strategic imperative for regulatory consultancy excellence
Customer advocacy is key to regulatory consultancy success. In life sciences, trust, transparency, and client-focused partnerships are essential for navigating complexity and driving performance.
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Managing risk for medical devices part 1
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation. In this edition we discuss which risk management principles are right for medical devices?
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CMC in Drug Development and Life Cycle Management
This blog provides emerging and biotech companies with a significant overview of the considerations for CMC. There are a multitude of complexities and points to consider when creating an asset and product development is at the centre
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Measuring the impact of ICH E9(R1) on UK research protocols
The ICH E9(R1) Addendum, adopted in November 2019, aims to clarify treatment effects in clinical trials. Tim Clark, ICON’s VP of Clinical Sciences, co-authored a study reviewing how UK research protocols apply estimands and how usage has evolved since the addendum’s adoption.
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Rising to the challenge with innovative therapies
Global regulators are streamlining access to innovative therapies—but navigating these pathways takes strategy. From FDA’s Breakthrough to EMA’s PRIME, early planning and expert partnerships make the difference.
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How Project Optimus has impacted oncology-focussed biotech companies
By focussing on dose-optimisation the FDA’s Project Optimus is changing how oncology-focussed biotechs develop their treatments.
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To avoid HTAR bottlenecks NICE and MHRA offer a strategic alternative
This blog explores how drug and medical device developers can engage with the MHRA and NICE as a strategic alternative when access to Joint Scientific Consultations (JSCs) is limited.
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The revision of ISO 10993-1 – what does it mean for medical devices?
Biological evaluation is a toxicological risk management process. The revised standard, expected by year-end, places it in proper context, emphasizing Clause 4's unchanged principles. The update aligns evaluation with ISO 14971 and accepted toxicological risk assessment practices.
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Why integration is essential for outsourced regulatory submissions
Greater efficiency in global regulatory submissions is possible with an integrated regulatory and translation services delivery model.
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Writing, managing, leading: the multifaceted role of a successful medical writer
This blog highlights the critical role of project management, leadership, and communication in medical writing. Learn how these skills contribute to high-quality, timely submissions.
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Project management tips for successful MAA, NDA or BLA submission preparation
From personalized medicine to AI-driven discovery, pharma innovation is accelerating. Gaining market approval requires strong cross-functional teamwork. This article shares project management tips to help you avoid pitfalls and prepare confident, high-quality submissions.
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Cultural shift of ISO 13485:2016 implementation for the FDA
In this blog, we explore the FDA’s Jan 2024 update to 21 CFR 820, now QMSR, aligning U.S. device standards with ISO 13485:2016 for global consistency.
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Driving MAA success: Why every submission team needs a regulatory project manager
Regulatory project managers are the guiding force behind successful MAA submissions. Learn about their role in delivering accelerated, harmonised, high-quality MAAs.
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When and why sponsors should seek MHRA advice
Sponsors can seek scientific advice from regulatory agencies for many reasons. Learn when to seek MHRA advice and the benefits in comparison to other agencies.
