IVD regulatory services, built into development

Helping you contain risks and embrace opportunities

Regulatory services

Our in-house regulatory team works alongside our CRO and CDMO teams to manage all of your regulatory requirements

Regulatory problems are rarely found when they are created. A specimen type left out of early studies, a claim that has outgrown its evidence or a design change made without an impact assessment tends to surface at submission, when it is slowest and most expensive to fix.

The regulatory landscape is very complex. Navigating multiple countries and regulatory approval pathways requires an understanding of all the different requirements at once. The good news is that Abingdon Health’s in-house IVD regulatory experts can manage your global regulatory needs, including FDA 510(k), De Novo and PMA submission support.

Abingdon Health regulatory and production teams

Self-test, point of care or lab based

Abingdon Health’s regulatory experts work with clients to meet any In Vitro Diagnostic regulatory filing, whether that be for self-test, point of care or lab based. Abingdon Health’s team has extensive experience in many territories including the USA, Canada, Australia, Brazil, the European Union and the UK. The team engages with the relevant regulatory bodies early on and initiates pre-submissions for products to ensure a smooth, timely and efficient regulatory pathway.

Our regulatory teams work hand in hand with our CRO and CDMO teams to provide a seamless service to ensure your product is delivered on time, on budget and in market.

What we deliver

Our services include

Technical file preparation

Preparing pre-submissions

Liaising with regulatory bodies

Preparing and managing Performance Evaluation

Regulatory strategy and gap analysis for each target market

Post-market surveillance, vigilance and change assessments

Performance evaluation

We also provide a comprehensive Performance Evaluation package to cover all your requirements to ensure the validation and verification of the performance of your lateral flow test. Analytical services include, inter alia, preparation of and execution of: analytical performance studies; clinical performance studies; stability trials; and transport studies. Where you need an independent test house, these studies can also be run by our independent, impartial analytical test house subsidiary, Abingdon Analytical.

Scientist reviewing AI-assisted results

Regulation that keeps pace with your technology

New formats raise new questions. A molecular hybrid test, a reader-based quantitative assay or an app that interprets diagnostic results can each change your classification and the evidence a reviewer expects. We look at those implications during feasibility, not just at submission. Where software or AI is involved, our 45+ strong team of regulatory professionals within our AI & MedTech division specialise in SaMD and AI regulation.

Representation, quality systems and post-market support

If you also need an EU Authorised Representative, UK Responsible Person, US Agent, PRRC services or ISO 13485 quality management system support our Diagnostics and AI & MedTech regulatory experts can help, so your regulatory work stays joined up.

From the Knowledge Centre

Read more on Regulatory services

Practical guidance from the specialists who deliver this work every day.

Article Navigating new UK medical device regulations: Action required now, help is on hand! Get advice and support on navigating new UK medical device regulations from lateral flow test manufacturer, Abingdon Health. Read on. 5 Sep 2022 · 5 min read

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Planning a submission?

Talk to our regulatory team about your pathway, evidence plan and timelines.

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